PENTAX
Report
- Report Number
- 2518897-2023-00046
- Event Type
- Injury
- Date Received
- September 6, 2023
- Date of Event
- August 11, 2023
- Report Date
- November 16, 2023
- Manufacturer
- HOYA CORPORATION PENTAX
- Product Code
- EOQ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
CORRECTION INFORMATION: B5. REFER TO H10, B7:OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS, F7: FOLLOW UP #02, F11: UPDATED DATES, F13: UPDATED DATES. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.
EVALUATION SUMMARY: THE 1ST PHASE OF INVESTIGATION MADE IT POSSIBLE TO IDENTIFY DAMAGE TO THE EB-1575K ENDOSCOPE SERIAL NUMBER: (B)(6) RECEIVED FOR MAINTENANCE UNDER OPERATION#: (B)(4). FOLLOWING THE USE OF DEFECTIVE BIOPSY FORCEPS. IT WAS NOTED ON (B)(6) 2023: DISTAL HEAD VERY DAMAGED BY THE INSTRUMENTS USED, PHOTO DISTAL END, CRUSHED OR DEFORMED OPERATING CHANNEL, OP CHANNEL CRUSHED AND OP CHANNEL CLOSED OUTPUT T-PIECE, OPERATING CHANNEL SCRATCHED BY THE INSTRUMENTS USED, OP CHANNEL SCRATCHED. WE RECEIVED THE 2 MICRO-TECH EBF33-11018120 BIOPSY FORCEPS FROM LOT#: MEB220831004 THAT CUSTOMER SENT US. ONE WAS SENT TO PENTAX EUROPE AND THE 2ND WAS USED FOR EQUIVALENCE TESTS ON AN EB-1575K. WITH A VERNIER CALIPER THE DIAMETER OF THE CLAMP WAS MEASURED: 1.8MM THE MENTION OF PAPER IN A PICTURE IS THE USE OF ROLLING CIGARETTE PAPER WHICH HAS A THICKNESS OF 0.02 ~ 0.03MM. WITH SEVERAL PAPERS, IT WAS OBTAINED A THICKNESS OF 0.24 AND 0.48 MM RESPECTIVELY FOR THE SIMULATION AND OBSERVED THAT THE BACK OF THE JAW CAN BE INSERTED INTO AN EB-1575K. BUT THE WITHDRAWAL TEST DID NOT GO ANY FURTHER BECAUSE THE OPERATING CHANNEL IS 2MM SO WITH A FORCEPS OF 1.8 PLUS 0.24MM WE REACH 2.04MM SO IT WAS DECIDED TO AVOID DAMAGING THE ENDOSCOPE: IT WAS NOTICED THAT WHEN THE CLAMP IS FULLY OPEN, AT THE BACK OF THE JAW, THE SHOULDER SHAPE: AND CAN BLOCK THE FORCEPS IF THE JAWS ARE NOT CORRECTLY CLOSED BY RELEASING THE HANDLE OR IF THE QUANTITY OF SAMPLE IS TOO LARGE. THE ROOT CAUSE IS ABNORMAL USE, I.E., THE USER DID NOT CARRY OUT MANDATORY CHECKS OF THE DEVICE PRIOR TO USE AS REQUESTED BY THE IFU. IT IS SUSPECTED THE FORCEPS MAY HAVE NOT BEEN COMPLETELY CLOSED WHEN THE USER TRIED TO RETRACT THEM. THIS CAN CAUSE DAMAGE TO THE INSTRUMENTATION CHANNEL. THE FOLLOWING WAS COMMUNICATED TO THE CUSTOMER: 1. THE BIOPSY FORCEPS IS COMPATIBLE WITH EB-1575K. 2. THE BIOPSY FORCEPS AND BRONCHOSCOPE SHOULD BE HANDLED EXACTLY AS DESCRIBED IN THE ENCLOSED USER MANUAL TO AVOID DAMAGE TO THE ENDOSCOPE. THIS BECOMES CRITICAL IF GRASPED TISSUE RESULTS IN A DIAMETER >2.0 MM WITH THE SPOONS/JAWS CLOSED. 3. THE BIOPSY FORCEPS IS IN WORKING CONDITION, NO MALFUNCTIONS/DEFECTS OBSERVED. 4. IF THE JAWS ARE OPENED EXCESSIVELY, THE SHOULDER MAY BLOCK THE REMOVAL OF THE BIOPSY FORCEPS. EXCESSIVE FORCE TO REMOVE THE INSTRUMENT MAY CAUSE KINKING/KINKING OF THE WORKING CHANNEL. A DEVICE HISTORY RECORD(DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED BY PENTAX MEDICAL MIYAGI ON (B)(6) 2015 UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO REWORKS OR CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED ON (B)(6) 2015. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.
F10 CONTINUED: INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING HEALTH EFFECT CLINICAL CODE: 2477 LOW OXYGEN SATURATION, HEALTH EFFECT IMPACT CODE: 4604 DELAY TO TREATMENT/THERAPY, MEDICAL DEVICE PROBLEM CODE: 4012 PHYSICAL RESISTANCE/STICKING, 2796 MATERIAL DEFORMATION. COMPONENT CODE: 525 TUBE. ADDITIONAL DETAILS PROVIDED: PATIENT IS A 23-YEAR-OLD FEMALE PATIENT REQUIRING BRONCHOSCOPY FOR SUSPECTED PULMONARY SARCOIDOSIS. DURING ENDOSCOPY, THERE WAS USE OF BRONCHIAL BIOPSY FORCEPS. DURING THE FIRST SAMPLING, THE REMOVAL OF THE FORCEPS WAS DIFFICULT. THE OPERATOR PERFORMED A WITHDRAWAL BY FORCING THE CLAMP, WHICH MADE IT IMPOSSIBLE TO REINTRODUCE INTO THE ENDOSCOPE. A CHANGE OF GRIPPER DID NOT RESOLVE THE DIFFICULTY. CURRENT CONDITION OF THE PATIENT: THE PATIENT'S TOLERANCE TO THE EXTENDED TIME OF THE EXAMINATION WAS POOR AND RESULTED IN OXYGEN DESATURATION. OXYGEN LEVELS DECREASED TO 88% AND REQUIRED OXYGEN THERAPY. THERE WAS ALSO MENTION OF A RISK OF MUCOSAL DAMAGE AND A RISK OF DAMAGING THE INNER SHEATH OF THE ENDOSCOPE AND CREATING A NICHE OF CONTAMINATION. PENTAX MEDICAL RECEIVED THE DEVICE WITHOUT THE BIOPSY FORCEPS USED IN THE PROCEDURE. THE INSERTION FLEXIBLE TUBE(IFT) IS A LITTLE BIT CRUSHED AT 350MM AND THE DISTAL END IS BROKEN. A BOROSCOPE INSPECTION WAS PERFORMED AND WE NOTICED: MANY SCRATCHES INTO THE OPERATIONAL CHANNEL, OPERATIONAL CHANNEL CRUSHED, AND BLACK STAIN DEPOSIT IN THE OPERATIONAL CHANNEL. THE INVESTIGATION IS IN-PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.
REFER TO H10.
PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 17-AUG-2023 THAT OCCURRED IN THE OPERATING ROOM DURING USE IN FRANCE ON (B)(6) 2023 INVOLVING A PENTAX MEDICAL BRONCHOSCOPE MODEL EB-1575K, SERIAL NUMBER (B)(6). DURING THE FIRST SAMPLING IT WAS DIFFICULT TO REMOVE THE FORCEPS. THE OPERATOR PERFORMED A WITHDRAWAL BY FORCING ON THE FORCEPS, WHICH THEN BECAME IMPOSSIBLE TO REINTRODUCE INTO THE ENDOSCOPE. A CHANGE OF FORCEPS DID NOT RESOLVE THE DIFFICULTY. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2156582 | PENTAX | VIDEO BRONCHOSCOPE | EOQ | HOYA CORPORATION PENTAX | EB-1575K |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Female | Required Intervention |