SINGLE USE DISTAL COVER
Report
- Report Number
- 3003637092-2022-00014
- Event Type
- Injury
- Date Received
- August 9, 2022
- Date of Event
- July 10, 2022
- Report Date
- December 8, 2023
- Manufacturer
- OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT
- Product Code
- FDT
- UDI-DI
- 04953170441271
- PMA / PMN Number
- K220587
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
THE SUSPECT WAS RETURNED TO OLYMPUS FOR EVALUATION. INSPECTION OF THE RETURNED DEVICE FOUND THE TIP OF THE DISTAL COVER WAS DAMAGED AND WAS EASILY REMOVED FROM THE SCOPE. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION AND THE RESULTS OF THE DEVICE HISTORY RECORD (DHR) REVIEW. NEW INFORMATION WAS ADDED TO THE FOLLOWING FIELDS: B5, H6, H10. THE DEVICE HISTORY RECORDS (DHR) FOR THIS DEVICE COULD NOT BE REVIEWED SINCE THE SERIAL NUMBER WAS NOT PROVIDED. OLYMPUS SHIPS DEVICES MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MEET FINAL PRODUCT RELEASE CRITERIA. THE LEGAL MANUFACTURER TRIED TO REPLICATE THE REPORTED FAILURE USING A DISTAL COVER (LOT. H1412), AND CONFIRMED THAT THE DISTAL COVER WILL NEVER COME OFF WHEN IT HAS NO DAMAGE AND IT IS CORRECTLY ATTACHED TO THE SCOPE. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED. SINCE THE COVER WAS NOT DAMAGED BEFORE USE, THE PROBABLE CAUSE OF THE COVER BEING DAMAGED AND DETACHED FROM THE SCOPE WAS LIKELY DUE TO SOME LOAD BEING APPLIED DURING USE. WHEN THE LEGAL MANUFACTURER MAGNIFIED AND OBSERVED THE INSIDE OF THE TIP OF THE RETURNED COVER, IT WAS CONFIRMED TO BE SCRATCHED. HOWEVER, SINCE THE INJURED PART IS NOT THE PART THAT COMES INTO CONTACT WITH THE TREATMENT INSTRUMENT, IT IS UNLIKELY THAT THE COVER WAS DAMAGED BY CONTACT WITH THE TREATMENT INSTRUMENT. INFORMATION PROVIDED INDICATES THAT THE COVER FELL OFF DURING STONE COLLECTION. WITH THE CALCULUS STUCK BEHIND THE FORCEPS BASE OF THE SCOPE, THE INSTRUMENT WAS INSERTED AND THE FORCEPS BASE WAS FORCIBLY KNOCKED DOWN. AS A RESULT, IT IS SPECULATED THAT THE CALCULUS WAS PRESSED STRONGLY AGAINST THE COVER AND THE COVER CRACKED. HOWEVER, EVEN IF THE FRONT END OF THE COVER IS BROKEN, THE REAR END OF THE COVER IS CAUGHT ON THE PROTRUSION OF THE SCOPE, SO IT WILL NOT FALL OFF. THE RETURNED COVER WAS BROKEN AT BOTH THE FRONT AND REAR ENDS, BUT IF BOTH ARE BROKEN, IT WILL NOT BE FIXED TO THE SCOPE AT ALL, SO IT WILL EASILY COME OFF THE SCOPE. THE POSSIBLE CAUSES FOR THE CRACK IN THE REAR EDGE OF THE COVER ARE AS FOLLOWS: DURING STORAGE, THE COVER WAS SUBJECTED TO A CRUSHING LOAD AND BECAME FRAGILE, AND THE BACK END OF THE COVER CRACKED DUE TO THE FRICTIONAL LOAD IN THE GASTROINTESTINAL TRACT DURING USE AND THE AFOREMENTIONED CALCULUS PRESSING LOAD. THE INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING: "7.3 ATTACHING THE DISTAL COVER" (P.11 TO P.13), PLEASE MAKE SURE THAT THE DISTAL COVER IS INTACT WITHOUT ANY PROBLEM BEFORE INSTALLATION, AND IT HAS NO DAMAGE(CRACK) AFTER INSTALLATION. ALSO, IF YOU FEEL ANY ABNORMALITY IN THE OPERATION, PLEASE STOP THE OPERATION AND CHECK THE DEVICE FOR ANY ABNORMALITY. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THE DEVICE.
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE CORRECTED INFORMATION BASED ON A FORMAL INVESTIGATION. ALSO CORRECTED H6 MEDICAL DEVICE PROBLEM CODE. VISUAL CONFIRMATION RESULT OF THE ACTUAL PRODUCT: THE RETURNED DISTAL COVER WAS FOUND TO BE DAMAGED AT THE FRONT AND REAR ENDS. ALSO, WE CONFIRMED THAT THERE WAS A SCRATCH ON THE INSIDE OF THE FRONT SIDE OF THE DISTAL COVER. RECONFIRMATION OF COMPLAINT FAILURE: A REPRODUCTION CONFIRMATION WAS PERFORMED ACCORDING TO THE PRE-USE INSPECTION PROCEDURE IN SECTION 7.3 OF THE INSTRUCTION MANUAL USING THE SAMPLE HELD AT THE HINODE PLANT, BUT IT WAS CONFIRMED THAT THE INDICATED EVENT WAS NOT REPRODUCED. (LOT OF THE MAJ-2315 USED FOR REPRODUCTION CONFIRMATION: (B)(4)). INVESTIGATION RESULTS OF PRODUCT SPECIFICATIONS: QUALITY EVALUATIONS OF PRODUCTION PROTOTYPES HAVE VERIFIED THAT THE DISTAL COVER WILL NOT COME OFF FROM THE ENDOSCOPE UNLESS THE DISTAL COVER IS DAMAGED, AS LONG AS IT IS PROPERLY ATTACHED WITHOUT ANY DAMAGE. SAMPLING INSPECTION RESULTS AT THE PARTS MANUFACTURER: THE PARTS SUPPLIER CONDUCTS SAMPLING INSPECTIONS OF 3 PARTS FOR EACH PRODUCTION LOT, AND CONFIRMS THAT THE PARTS CONFORM TO THE SPECIFICATIONS. OLYMPUS CONFIRMED THE FOLLOWING ADDITIONAL INFORMATION: NO ANTI-FOGGING AGENT IS USED. THERE WAS NO DAMAGE TO THE COVER BEFORE USE. THIS EVENT OCCURRED WHEN THE STENT WAS PUSHED STRONGLY BECAUSE THE STENT DID NOT PASS THROUGH. THE CUSTOMER DID NOT MENTION THE MOVEMENT OF THE FORCEPS ELEVATOR. BASED ON THE VISUAL CONFIRMATION RESULT, THE REPRODUCTION CONFIRMATION RESULTS, INVESTIGATION RESULTS OF PRODUCT SPECIFICATIONS, AND THE INSPECTION RESULTS AT THE PARTS MANUFACTURER, IT IS BELIEVED THAT THE PRODUCT CONFORMED TO THE SPECIFICATIONS. HOWEVER, THE EXACT CAUSE OF THIS EVENT COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE POSSIBLE CAUSES OF THE DISTAL COVER FALLING OFF BASED ON THE ABOVE INVESTIGATION RESULTS ARE AS FOLLOWS: THE RETURNED DISTAL COVER WAS BROKEN AT BOTH THE FRONT AND REAR END. IF BOTH ARE BROKEN, THEY WILL NOT BE FIXED TO THE ENDOSCOPE AT ALL. THEREFORE, IT IS THOUGHT THAT THE DISTAL COVER WAS IN A STATE WHERE IT WAS EASY TO COME OFF THE ENDOSCOPE. THE CAUSES OF DAMAGE TO THE FRONT AND REAR ENDS OF THE DISTAL COVER ARE PRESUMED TO BE AS FOLLOWS: SINCE THE DISTAL COVER FELL OFF DURING QUARRYING, IT IS THOUGHT THAT THE FRONT END OF THE COVER WAS CRACKED WHEN THE FORCEPS BASE WAS FORCIBLY KNOCKED DOWN WITH THE STENT WHILE THE BACK OF THE FORCEPS BASE WAS CLOGGED WITH CALCULUS. AS A RESULT, IT IS THOUGHT THAT THE DISTAL COVER WAS IN A STATE WHERE IT WAS EASY TO COME OFF THE SCOPE. HOWEVER, ALTHOUGH WE KNOW FROM THE ADDITIONAL INFORMATION THAT THE STENT WAS PUSHED HARD, THE CUSTOMER DID NOT POINT OUT THE MALFUNCTION OF THE FORCEPS TABLE, SO WE COULD NOT DETERMINE WHETHER THE CALCULUS CLOGGING WAS THE CAUSE OF THE BREAKAGE. THE CAUSES OF THE CRACK AT THE REAR END OF THE COVER ARE AS FOLLOWS: THE REAR END OF THE COVER CRACKED DUE TO THE LOAD OF FRICTION IN THE GASTROINTESTINAL TRACT DURING USE AND THE LOAD DUE TO CONTACT WITH CALCULUS. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE CUSTOMER. B5 UPDATED.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. AN INTERVIEW WAS CONDUCTED BY OLYMPUS WITH THE FACILITY AS PART OF THE ROOT CAUSE INVESTIGATION PER CAPA-200735. IT WAS REPORTED THAT THE FACILITY CURRENTLY USES THE NEW DESIGN OF THE DISTAL COVER (MAJ-2315). REGARDING THE PREVENTION OF THE DETACHMENT OF THE DISTAL COVER FROM RECURRING, THE FACILITY, THE FOLLOWING WAS CONFIRMED: THE FACILITY DID NOT RECONFIRM THE CORRECT OPERATION METHOD BY CONTACTING OLYMPUS OR ANOTHER EXPERT WITHIN THEIR FACILITY. THE FACILITY DID NOT CAREFULLY REVIEW AND FOLLOW THE INSTRUCTION MANUAL. THE FACILITY DID NOT EDUCATE OR CONTINUOUSLY EDUCATE ITS PERSONNEL ABOUT HANDLING METHODS. THE FACILITY DID NOT INSPECT THE DISTAL COVER PRIOR TO ATTACHMENT. THE FACILITY DID NOT USE CARE WHEN ATTACHING THE DISTAL COVER, SO THAT IT DOES NOT CRACK. IN ADDITION TO THE ABOVE, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE INTERVIEWEE WAS NOT PRESENT WHEN THE PREVIOUSLY REPORTED COMPLAINT OCCURRED (DETACHMENT OF DISTAL COVER). AFTER THE REPORTED EVENT (DETACHMENT OF DISTAL COVER) OCCURRED, NO TRAINING WAS PROVIDED TO THE DEVICE USERS INVOLVED. REGARDING THE DETACHMENT OF THE DISTAL COVER, THE PHYSICIAN STATES THAT HE ¿PUT A LOT OF EFFORT INTO OPERATING THE TREATMENT DEVICE.¿ HOWEVER, THE PHYSICIAN DOES NOT REMEMBER EXACTLY HOW MUCH FORCE HE APPLIED. THE FACILITY IS CURRENTLY ¿NOT WORRIED¿ ABOUT THE DISTAL COVER FALLING OFF. THE USER IS VERY CAREFUL WHEN INSTALLING THE OLD COVER TO AVOID CRACKS. THE USER VISUALLY CONFIRMS THAT THE COVER DOES NOT COME OFF AND THAT THE HOOK IS FIRMLY HOOKED. AN EXPERIENCED DEVICE USER WILL COMMUNICATE WITH ALL NEW DEVICE USERS. THERE IS A DOCUMENT (IN FOLDER) WITH INFORMATION AND LEARNING MATERIAL ON OPERATING THE DEVICE. ALTHOUGH IT WAS NOT CONFIRMED, BASED ON THE INFORMATION RECEIVED IT IS ASSUMED THAT THERE HAS BEEN NO CHANGE IN THE STORAGE METHOD OF THE DISTAL COVERS SINCE EXPERIENCING THE DETACHMENT ISSUE. THE DISTAL COVERS ARE KEPT IN THEIR PRODUCT CARTON AND STORED IN A DRAWER. SOME DISTAL COVER STERILIZATION PACKS ARE REMOVED FROM THE PRODUCT CARTON AND STORED IN THE SAME DRAWER. THE FACILITY REPORTED THAT THEY DO NOT KNOW THE SPECIFIC CHEMICALS USED WHEN THE DISTAL COVER DETACHED; THEREFORE, THE INFORMATION BELOW IS BASED ON THE CURRENT PROCESS. ALTHOUGH IT WAS CONFIRMED THAT NO LUBRICANTS ARE APPLIED TO THE DISTAL END OF THE ENDOSCOPE, IT IS POSSIBLE THAT AN ANTI-FOG SOLUTION MAY BE USED. WHETHER THE APPLICATION METHOD IS DIRECT OR SOAKED IN GAUZE DEPENDS ON THE PHYSICIAN PERFORMING THE PROCEDURE. DIMETHICONE (DEFOAMER) IS ADMINISTERED DIRECTLY INTO THE BODY THROUGH THE FORCEPS CHANNEL DURING ENDOSCOPE INSERTION AND SENT TO THE FORCEPS CHANNEL TO LUBRICATE. ACCORDING TO THE PACKAGE INSERT, 2 ML TO 4 ML OF THIS DRUG IS TO BE DILUTED WITH 10 ML OF WATER; HOWEVER, BASED ON THE OBSERVATION BY OLYMPUS, THE FACILITY DOES NOT FOLLOW THIS RECOMMENDED CONCENTRATION. CONTRAST (UROGRAFIN) IS ADMINISTERED THROUGH THE CANNULA DURING THE ENDOSCOPE INSERTION. XYLOCAINE SPRAY (8%) AND XYLOCAINE VISCOUS ARE ADMINISTERED ORALLY TO THE PATIENT BEFORE THE INSPECTION. WATER WITH DIMETHICONE IS USED DURING ENDOSCOPE PREPARATION AND PRE-USE INSPECTION. IN ADDITION TO THE CHEMICALS/SOLUTIONS MENTIONED ABOVE, XYLOCAINE JELLY (2%) AND CAIN ZERO JELLY ARE PRESENT ON THE ENDOSCOPE TOWER IN THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) ROOM. IT WAS CONFIRMED THAT A CRACK HAS NEVER BEEN OBSERVED ON THE DISTAL COVER BEFORE ATTACHING IT TO THE ENDOSCOPE. HOWEVER, ONE TIME WHILE USING THE OLD DESIGN OF THE DISTAL COVER, THE DEVICE CRACKED WHILE INSTALLING IT. THIS HAS NEVER OCCURRED SINCE USING THE NEW DESIGN OF THE DISTAL COVER. THE FACILITY STATES THAT THE DISTAL COVER HAS BECOME EASIER TO INSTALL BECAUSE THE TIP IS NO LONGER ¿BREAKING.¿ THERE HAVE BEEN NO CRACKS OBSERVED ON THE REAR END OF THE DEVICE.
THIS REPORT IS BEING SUPPLEMENTED TO CORRECT D4 - UNIQUE IDENTIFIER (UDI) NUMBER. SINCE THE LOT NUMBER IS UNKNOWN AT THIS TIME, THE UDI IS EITHER (B)(4). DEPENDING ON THE LOT NUMBER USED.
THE FACILITY REPORTED TO OLYMPUS DURING A THERAPEUTIC STONE REMOVAL PROCEDURE, THE DISTAL COVER FELL OFF OF THE ENDOSCOPE AND INTO THE PATIENT WHILE THE PHYSICIAN WAS PICKING STONES WITH A BASKET FORCEPS. THE PHYSICIAN HEARD A NOISE WHEN THE DISTAL COVER FELL OFF. THE PHYSICIAN USED AN UNKNOWN ENDOSCOPE TO RETRIEVE THE DISTAL COVER FROM INSIDE THE PATIENT. THE CUSTOMER REPORTED THE PROCEDURE WAS COMPLETED HOWEVER NO ADDITIONAL DETAIL WAS PROVIDED. THE CUSTOMER ALSO REPORTED NO INJURY TO THE PATIENT OCCURRED. IT IS UNKNOWN IF THERE WAS A PROCEDURAL DELAY. A REQUEST FOR ADDITIONAL INFORMATION IS IN PROGRESS. THIS EVENT INCLUDES TWO (2) REPORTS: PATIENT IDENTIFIER (B)(6) : MAJ-2315, LOT UNKNOWN. PATIENT IDENTIFIER (B)(6): TJF-Q290V, 2111025. THIS REPORT IS 1 OF 2 FOR PATIENT IDENTIFIER (B)(6): MAJ-2315, LOT UNKNOWN.
ADDITIONAL INFORMATION WAS RECEIVED: THE CUSTOMER DOES NOT USE ANTI-FOG AGENTS, AND THE CUSTOMER TYPICALLY CONFIRMS THE COVER IS NOT DAMAGED BEFORE USE.
THE CUSTOMER PROVIDED ADDITIONAL INFORMATION: DURING THE THERAPEUTIC PROCEDURE, THE SURGEON WAS PICKING STONES WITH BASKET FORCEPS WHEN IT MADE A NOISE AND THE CAP FELL OFF IN AN UNKNOWN LOCATION OF THE PATIENT. IT IS UNKNOWN WHEN DURING THE PROCEDURE THIS HAPPENED. AFTER COMPLETION OF THE PROCEDURE, ANOTHER ENDOSCOPE WAS USED TO RETRIEVE THE RETAINED DISTAL COVER. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE BASKET MANUFACTURER, MODEL AND SERIAL NUMBER ARE UNKNOWN. IT IS UNKNOWN IF ANY CHEMICALS WERE USED DURING THE PROCEDURE TO THE TIP OF THE SCOPE OR THE DISTAL COVER. THE CUSTOMER CONFIRMED THE DISTAL COVER WAS NOT DAMAGED BEFORE USE. IT IS UNKNOWN IF THE DISTAL COVER WAS TESTED TO ENSURE SECURE ATTACHMENT TO THE SCOPE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302228 | SINGLE USE DISTAL COVER | ENDOSCOPE PATIENT PROTECTION CAP, SINGLE-USE | FDT | OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT | MAJ-2315 | UNKNOWN | 04953170441271 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other| R | TJF-Q290V, SERIAL NUMBER (B)(6). |