ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
Report
- Report Number
- 3001845648-2023-00369
- Event Type
- Injury
- Date Received
- May 18, 2023
- Date of Event
- April 19, 2023
- Report Date
- July 7, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCG
- UDI-DI
- 10827002535852
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PMA/510(K) # K210476. INVESTIGATION IS STILL PENDING, A FOLLOW-UP MDR REPORT WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # K210476. DEVICE EVALUATION: THE ECHO-HD-19-C DEVICE OF LOT NUMBER C1755647 WAS RETURNED FOR EVALUATION WITHOUT THE ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 10 MAY 2023. THE RETURNED DEVICE LAB FINDINGS AND OBSERVATIONS CAN BE REFERRED THROUGH THE ATTACHED FILES. ON EVALUATION THE BELOW OBSERVATIONS WERE MADE: THE SHEATH AND NEEDLE WERE OBSERVED TO BE SEPARATED/ BROKE BELOW SHEATH EXTENDER, PROXIMAL NEEDLE BREAK OBSERVED, TWO HOLES WERE OBSERVED ON THE SHEATH, BENDS AND TWISTS WERE OBSERVED ON THE SHEATH, THE NEEDLE HANDLE WAS ABLE TO ADVANCE AND RETRACT WITH NO ISSUES AND THE SHEATH EXTENDER WAS ABLE TO ADVANCE AND RETRACT WITH NO ISSUES. A LAB RE-EVALUATION WAS DONE ON 25 MAY 2023 AND THE BELOW OBSERVATIONS WERE MADE: THE STYLET WAS NOT RETURNED WITH THE DEVICE, APPROX. 9CM FROM DISTAL TIP OF SHEATH, A BEND WAS OBSERVED (IPE0504-4), THE DISTAL TIP OF SHEATH WAS EXAMINED, AND NO ISSUES WERE OBSERVED, SHEATH EXAMINED AND MULTIPLE BENDS OBSERVED, PROXIMAL BREAK WAS OBSERVED BELOW SHEATH EXTENDER IN LINE WITH MLLA POSITION 1.5. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION, ALL ECHO-HD-19-C DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. AN NC CODE ( PAC-002) EMBEDDED IN PACKAGING)WAS NOTED ON THE WORK ORDER, HOWEVER THIS WAS SUBSEQUENTLY REWORKED AND WOULD NOT HAVE ATTRIBUTED TO THIS COMPLAINT ISSUE. REVIEW HISTORICAL DATA: THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED FOR C1755647. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1755647. INSTRUCTIONS FOR USE AND LABEL: THE NOTES SECTION OF THE INSTRUCTIONS FOR USE (IFU0077), WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO; "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE" AND "ENSURE THE STYLET IS FULLY INSERTED WHEN ADVANCING THE NEEDLE INTO THE BIOPSY SITE". IN THE ADDITIONAL INFORMATION USER STATES THE STYLET WAS PARTIALLY REMOVED WHILE ADVANCING THE NEEDLE. ¿Q. WAS THE STYLET PARTIALLY REMOVED WHEN ADVANCING THE NEEDLE INTO THE TARGET SITE? YES¿ THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. IMAGE REVIEW: A PHOTO WAS RECEIVED WHICH SHOWED THE BROKEN SECTION OF THE NEEDLE THAT WAS RETRIEVED FROM THE PATIENT'S STOMACH. THE BROKEN SECTION OF THE NEEDLE IS ALSO KINKED IN THE MIDDLE. ROOT CAUSE ANALYSIS: DEFINITIVE ROOT CAUSE WAS ESTABLISHED. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU. IT IS KNOWN FROM THE AVAILABLE INFORMATION THAT THE USER ADVANCED THE NEEDLE INTO THE TARGET SITE WITH THE STYLET PARTIALLY REMOVED. AS THE STYLET SHOULD BE FULLY INSERTED WHEN ADVANCING THE NEEDLE INTO THE BIOPSY SITE. POTENTIALLY THE USER ERROR SITUATION COULD HAVE CONTRIBUTED TO THE DISTAL NEEDLE BREAK, PROXIMAL NEEDLE BREAK, DISTAL NEEDLE KINK AND SHEATH BREAKAGE. HAVING THE STYLET IN THE CORRECT POSITION WILL REDUCE THE IMPACT ONTO THE NEEDLE AND BY RETRACTING THE STYLET IT EXPOSES THE NEEDLE TO EXTRA FORCE. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON VISUAL AND/OR FUNCTIONAL INSPECTION. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. SUMMARY OF INVESTIGATION: ACCORDING TO THE INITIAL REPORTER, THE BROKEN DISTAL NEEDLE PART WAS DISCOVERED IN THE PATIENT DURING AN X-RAY AND AS PER PRODUCT MANGER THIS NEEDLE PART WAS RECOVERED FROM THE PATIENT USING A GRASPING FORCEPS. CONFIRMED QUANTITY OF 01 DEVICE, CONFIRMED USED. ACCORDING TO THE INITIAL REPORT, THE PATIENT UNDERWENT AN ERCP TO RETRIEVE THE BROKEN NEEDLE. INVESTIGATION FINDINGS CONCLUDE THAT A DEFINITIVE ROOT CAUSE OF USER ERROR WAS ESTABLISHED.
PMA/510(K) # K210476. INVESTIGATION IS STILL PENDING, A FOLLOW-UP MDR REPORT WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF A LAB RE-EVALUATION ON 25-MAY-2023.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON THE 07-JUL-2023.
(B)(6) 2023: NEEDLE CAME OUT OF PLASTIC SHEATH NEAR HUB AND OUT OF PLASTIC COATING. (B)(6) 2023: REP CALLED BACK INTO STATE THAT THE PHYSICIAN CALLED AND REPORTED THAT A PIECE OF THE DEVICE BROKE OFF IN PATIENT. THIS WAS DISCOVERED WHILE THE PATIENT WAS STILL AN INPATIENT AND DURING AN X-RAY FOR SOMETHING ELSE. PATIENT WAS NOT COMPLAINING OF ANY PAIN OR DISCOMFORT. PATIENT OUTCOME: THE FOLLOWING INFORMATION HAS BEEN RECEIVED VIA PHONE CALL ON (B)(6) 2023. SG (B)(6) 2023. 1. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. 2. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? NO. 3. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. 4. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO. 5. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. 6. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? N/A. THE FOLLOWING INFORMATION HAS BEEN RECEIVED VIA PHONE CALL ON (B)(6) 2023. SG (B)(6) 2023. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? YES. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? PATIENT WAS ALREADY AN INPATIENT. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? YES, A ERCP TODAY ((B)(6) 2023). DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? YES. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? N/A. PATIENT/EVENT INFO - NOTES: THE FOLLOWING INFORMATION HAS BEEN RECEIVED VIA PHONE CALL ON (B)(6) 2023. SG (B)(6) 2023. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? NO. IF THE REPORT INVOLVES A KINK OR BEND IN THE NEEDLE, WHERE IS THIS LOCATED ON THE DEVICE (HANDLE END (PROXIMAL END) OR PATIENT END (DISTAL END))? N/A, HANDLE END, PATIENT END) UNKNOWN. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINK)? NO. IF THE DEVICE WAS KINKED BELOW THE SHEATH EXTENDER, WAS THE KINK OBSERVED BEFORE INSERTING THE DEVICE INTO THE SCOPE? NO. IF THE DEVICE IS A PROCORE NEEDLE, IS THE DEVICE DAMAGE LOCATED AT THE NOTCH / CORE TRAP? NO. ¿ IF NO, PLEASE SPECIFY WHERE THE DAMAGE IS LOCATED: NEAR HUB. WAS GAINING ACCESS TO THE TARGET SITE DIFFICULT? UNKNOWN. WAS THE DEVICE USED IN A TORTUOUS POSITION? UNKNOWN. WAS PUNCTURE OF THE TARGET SITE DIFFICULT? UNKNOWN. PLEASE DESCRIBE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE (PANCREAS, STOMACH, LUNGS ETC.). UNKNOWN, BUT BELIEVED TO BE PANCREAS. PLEASE DESCRIBE THE SIZE OF THE INTENDED TARGET SITE. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE PERFORMED AND/OR FINISHED? ALTERNATIVE NEEDED, NOT COOK. WAS THE DEVICE DAMAGED IN PACKAGING PRIOR TO REMOVAL? UNKNOWN. WAS THE DEVICE DAMAGED ON REMOVAL FROM PACKAGING? UNKNOWN. WAS FORCE REQUIRED TO REMOVE THE DEVICE? UNKNOWN. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? NO. WHAT INTERVENTION (IF ANY) WAS REQUIRED? N/A. WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? N/A, WERE ANY OTHER DEFECTS OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINKS, BENDS, BREAKS ETC.)? N/A. WHAT IS THE SCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? OLYMPUS. WAS RESISTANCE FELT WHILE INSERTING THE DEVICE THROUGH THE SCOPE? UNKNOWN. WAS THE SCOPE RECENTLY SERVICED / REPAIRED? UNKNOWN. WHEN WAS THE ISSUED WITH THE PRODUCT NOTED? ON ADVANCEMENT OF THE SHEATH/NEEDLE OR ON NEEDLE RETRACTION? UNKNOWN. WAS THE SYRINGE USED DURING THE PROCEDURE, AFTER THE STYLET WAS REMOVED? UNKNOWN WAS DIFFICULTY EXPERIENCED WHILE RETRACTING THE NEEDLE? UNKNOWN. WAS IT POSSIBLE TO FULLY RETRACT THE NEEDLE INTO THE SHEATH BEFORE REMOVING THE DEVICE FROM THE PATIENT? UNKNOWN. WAS THE ENDOSCOPE IN A FLEXED OR TWISTED POSITION AT ANY TIME DURING THE PROCEDURE? UNKNOWN. WAS THE STYLET PARTIALLY REMOVED WHEN ADVANCING THE NEEDLE INTO THE TARGET SITE? UNKNOWN. HOW MANY SAMPLES WERE OBTAINED (PASSES COMPLETED) WITH THIS NEEDLE? UNKNOWN. DID ANY SECTION OF THE DEVICE DETACH INSIDE THE PATIENT? NO. WAS THERE DIFFICULTY LOCKING THE SHEATH (OR NEEDLE) IN PLACE OR SLIPPING EXPERIENCED DURING USE? UNKNOWN. WAS THERE DIFFICULTY IN ATTACHING OR DETACHING THE DEVICE TO THE ACCESSORY CHANNEL PORT ON THE SCOPE? UNKNOWN. WHEN THE NEEDLE TIP WAS ADVANCED INTO THE TARGET SITE WAS THE DISTAL SCOPE POSITION ADJUSTED SO AS TO STRAIN OR FLEX THE NEEDLE? UNKNOWN. IF AN EBUS PROCEDURE DID THE NEEDLE TIP HIT THE CARTILAGE RINGS OF THE TRACHEA? NOT EBUS PLEASE PROVIDE THE ORIGINATOR A LIST OF ANY ADDITIONAL MANUFACTURER QUESTIONS REQUIRED FOR INVESTIGATION. SG (B)(6) 2023 THE FOLLOWING INFORMATION HAS BEEN RECEIVED VIA PHONE CALL ON (B)(6) 2023. SG (B)(6) 2023 REP WILL BE SPEAKING WITH THE PHYSICIAN THIS EVENING OR TOMORROW AND WILL PROVIDE AN UPDATE. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? YES WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? ANOTHER DAY. THE FOLLOWING INFORMATION HAS BEEN REQUESTED VIA EMAIL ON (B)(6) 2023. SG (B)(6) 2023 PATIENT INFORMATION: (PRE-EXISTING CONDITIONS, GENDER, AGE, WEIGHT): ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? IF THE REPORT INVOLVES A KINK OR BEND IN THE NEEDLE, WHERE IS THIS LOCATED ON THE DEVICE (HANDLE END (PROXIMAL END) OR PATIENT END (DISTAL END))? WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINK)? IF THE DEVICE WAS KINKED BELOW THE SHEATH EXTENDER, WAS THE KINK OBSERVED BEFORE INSERTING THE DEVICE INTO THE SCOPE? WAS GAINING ACCESS TO THE TARGET SITE DIFFICULT? WAS THE DEVICE USED IN A TORTUOUS POSITION? WAS PUNCTURE OF THE TARGET SITE DIFFICULT? PLEASE DESCRIBE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE (PANCREAS, STOMACH, LUNGS ETC.). UNKNOWN, BUT BELIEVED TO BE PANCREAS PLEASE DESCRIBE THE SIZE OF THE INTENDED TARGET SITE. WAS THE DEVICE DAMAGED IN PACKAGING PRIOR TO REMOVAL? WAS THE DEVICE DAMAGED ON REMOVAL FROM PACKAGING? WAS FORCE REQUIRED TO REMOVE THE DEVICE? WERE ANY OTHER DEFECTS OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINKS, BENDS, BREAKS ETC.)? WAS RESISTANCE FELT WHILE INSERTING THE DEVICE THROUGH THE SCOPE? WAS THE SCOPE RECENTLY SERVICED / REPAIRED? WHEN WAS THE ISSUED WITH THE PRODUCT NOTED? ON ADVANCEMENT OF THE SHEATH/NEEDLE OR ON NEEDLE RETRACTION? WAS THE SYRINGE USED DURING THE PROCEDURE, AFTER THE STYLET WAS REMOVED? WAS DIFFICULTY EXPERIENCED WHILE RETRACTING THE NEEDLE? WAS IT POSSIBLE TO FULLY RETRACT THE NEEDLE INTO THE SHEATH BEFORE REMOVING THE DEVICE FROM THE PATIENT? WAS THE ENDOSCOPE IN A FLEXED OR TWISTED POSITION AT ANY TIME DURING THE PROCEDURE? WAS THE STYLET PARTIALLY REMOVED WHEN ADVANCING THE NEEDLE INTO THE TARGET SITE? HOW MANY SAMPLES WERE OBTAINED (PASSES COMPLETED) WITH THIS NEEDLE? WAS THERE DIFFICULTY LOCKING THE SHEATH (OR NEEDLE) IN PLACE OR SLIPPING EXPERIENCED DURING USE? WAS THERE DIFFICULTY IN ATTACHING OR DETACHING THE DEVICE TO THE ACCESSORY CHANNEL PORT ON THE SCOPE? WHEN THE NEEDLE TIP WAS ADVANCED INTO THE TARGET SITE WAS THE DISTAL SCOPE POSITION ADJUSTED SO AS TO STRAIN OR FLEX THE NEEDLE? THE FOLLOWING INFORMATION HAS BEEN RECEIVED VIA EMAIL ON (B)(6) 2023. SG (B)(6) 2023 ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? YES, DEVICE RETURNED TO THE COMPANY FOR REVIEW IF THE REPORT INVOLVES A KINK OR BEND IN THE NEEDLE, WHERE IS THIS LOCATED ON THE DEVICE (HANDLE END (PROXIMAL END) OR PATIENT END (DISTAL END))? NEEDLE MALFUNCTIONED WHERE THE NEEDLE TIP BROKE OFF FROM THE ENTIRE PROCORE PLATFORM. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINK)? NOTICED THAT THE PLASTIC SHEATH WAS COMPROMISED WITH A HOLE APPROXIMATELY 5-10CM BELOW THE HUB (LUER LOCK). NEEDLE CAME OUT THROUGH THE SIDE OF THE PROTECTIVE PLASTIC SHEATH . IF THE DEVICE WAS KINKED BELOW THE SHEATH EXTENDER, WAS THE KINK OBSERVED BEFORE INSERTING THE DEVICE INTO THE SCOPE? NO . WAS GAINING ACCESS TO THE TARGET SITE DIFFICULT? NO . WAS THE DEVICE USED IN A TORTUOUS POSITION? NO . WAS PUNCTURE OF THE TARGET SITE DIFFICULT? NO . PLEASE DESCRIBE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE (PANCREAS, STOMACH, LUNGS ETC.). CELIAC METASTATIC LN . PLEASE DESCRIBE THE SIZE OF THE INTENDED TARGET SITE. 5CM. WAS THE DEVICE DAMAGED IN PACKAGING PRIOR TO REMOVAL? NO. WAS THE DEVICE DAMAGED ON REMOVAL FROM PACKAGING? NO . WAS FORCE REQUIRED TO REMOVE THE DEVICE? NO.. WERE ANY OTHER DEFECTS OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINKS, BENDS, BREAKS ETC.)? TECH NOTICED THE ENTIRE PLASTIC SHEATH WAS DISCONNECTED FROM THE PROCORE NEEDLE WHEN PACKAGING IT UP FOR RETURN TO MANUFACTURER . WAS RESISTANCE FELT WHILE INSERTING THE DEVICE THROUGH THE SCOPE? NO. WAS THE SCOPE RECENTLY SERVICED / REPAIRED? UNKNOWN. WHEN WAS THE ISSUED WITH THE PRODUCT NOTED? ON ADVANCEMENT OF THE SHEATH/NEEDLE OR ON NEEDLE RETRACTION? WHEN STYLET COULD NOT BE PLACED BACK INTO THE NEEDLE TO COLLECT CORE SPECIMEN. WAS THE SYRINGE USED DURING THE PROCEDURE, AFTER THE STYLET WAS REMOVED? YES. WAS DIFFICULTY EXPERIENCED WHILE RETRACTING THE NEEDLE? NO. WAS IT POSSIBLE TO FULLY RETRACT THE NEEDLE INTO THE SHEATH BEFORE REMOVING THE DEVICE FROM THE PATIENT? YES. WAS THE ENDOSCOPE IN A FLEXED OR TWISTED POSITION AT ANY TIME DURING THE PROCEDURE? NO. WAS THE STYLET PARTIALLY REMOVED WHEN ADVANCING THE NEEDLE INTO THE TARGET SITE? YES. HOW MANY SAMPLES WERE OBTAINED (PASSES COMPLETED) WITH THIS NEEDLE? FIRST PASS WAS EXCELLENT, GOOD CORE TISSUE WAS OBTAINED. MALFUNCTION OCCURRED WITH 2ND PASS WAS THERE DIFFICULTY LOCKING THE SHEATH (OR NEEDLE) IN PLACE OR SLIPPING EXPERIENCED DURING USE? NO . WAS THERE DIFFICULTY IN ATTACHING OR DETACHING THE DEVICE TO THE ACCESSORY CHANNEL PORT ON THE SCOPE? NO . WHEN THE NEEDLE TIP WAS ADVANCED INTO THE TARGET SITE WAS THE DISTAL SCOPE POSITION ADJUSTED SO AS TO STRAIN OR FLEX THE NEEDLE? NO. THE FOLLOWING INFORMATION HAS BEEN REQUESTED VIA EMAIL ON (B)(6) 2023. SG (B)(6) 2023 THE INVESTIGATING TEAM WOULD LIKE TO KNOW WHY THE STYLET AND THE LARGE SECTION OF THE NEEDLE WERE NOT RETURNED?
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1695695 | ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | C1755647 | 10827002535852 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Female | Required Intervention |