PENTAX
Report
- Report Number
- 9610877-2023-00219
- Event Type
- Malfunction
- Date Received
- September 6, 2023
- Date of Event
- August 9, 2023
- Report Date
- November 16, 2023
- Manufacturer
- HOYA CORPORATION PENTAX TOKYO OFFICE
- Product Code
- EOQ
- PMA / PMN Number
- K200678
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
CORRECTION INFORMATION. B4: DATE OF THIS REPORT. G6: FOLLOW UP #1. H2: IF FOLLOW-UP, WHAT TYPE? H3: DEVICE EVALUATED BY MANUFACTURE. H5: LABELED FOR SINGLE USE? H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT. ADDITIONAL INFORMATION: B7:OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS. D4;UNIQUE IDENTIFIER (UDI). H4: DEVICE MANUFACTURE DATE. EVALUATION SUMMARY: THE 1ST PHASE OF INVESTIGATION MADE IT POSSIBLE TO IDENTIFY DAMAGE TO THE EB-1575K ENDOSCOPE #H120936 RECEIVED FOR MAINTENANCE UNDER OPERATION #5250068258 FOLLOWING THE USE OF DEFECTIVE BIOPSY FORCEPS. IT WAS NOTED ON AUGUST 24, 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 PENTAX MEDICAL MIYAGI ON 15-DEC-2017 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 15-DEC-2017. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.
ADDITIONAL DETAILS PROVIDED: 56-YEAR-OLD PATIENT TREATED FOR BRONCHIAL ENDOSCOPIC ECHO WITH ULTRASOUND-GUIDED TRANSBRONCHIAL PUNCTURE FOR EXPLORATION OF PULMONARY INVOLVEMENT OF STILL'S DISEASE. DURING THE FIRST BIOPSY, THE OPERATOR HAS DIFFICULTY REMOVING THE BIOPSY FORCEPS FROM THE ENDOSCOPE. THE OPERATOR PERFORMS A FORCEFUL WITHDRAWAL, AND CAN NO LONGER REINTRODUCE THE CLAMP FOR THE NEXT SAMPLING. THE SAME PROBLEM OCCURS AGAIN WITH A 2ND CLAMP OF THE SAME BATCH. THE OPERATOR THEN USES A 3RD CLAMP OF AN OTHER MANUFACTURER TO CARRY OUT THE OTHER SAMPLES. CURRENT CONDITION OF THE PATIENT: THE PATIENT HAS NO COMPLICATIONS. THERE WAS ALSO MENTION OF A RISK OF MUCOSAL DAMAGE AND A RISK OF DAMAGING THE INNER SHEATH OF THE ENDOSCOPE AND LONGER EXAMINATION TIME. PENTAX MEDICAL RECEIVED THE DEVICE WITHOUT THE BIOPSY FORCEPS USED INT HE PROCEDURE. THE INSERTION FLEXIBLE TUBE(IFT) IS CRUSHED AT 350MM AND 410MM, DISTAL END HAS BIG MARKS LET BY INSTRUMENTS. A BOROSCOPE INSPECTION WAS PERFORMED AND WE NOTICED: MANY SCRATCHES INTO THE OP CHANNEL, OP CHANNEL CRUSHED / DEFORMED AT DIFFERENT LOCATIONS, OP CHANNEL TWISTED AT T PIECE SIDE, IMPORTANT BLACK STAINS DEPOSIT IN THE OP CHANNEL. THE INVESTIGATION IS IN-PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.
DURING THE FIRST BIOPSY, THE OPERATOR HAS DIFFICULTY REMOVING THE BIOPSY FORCEPS FROM THE ENDOSCOPE. THE OPERATOR PERFORMS A FORCEFUL WITHDRAWAL, AND CAN NO LONGER REINTRODUCE THE FORCEPS FOR THE NEXT SAMPLING. THE SAME PROBLEM OCCURS AGAIN WITH A 2ND FORCEPS OF THE SAME BATCH. THE OPERATOR THEN USES A 3RD FORCEPS FROM ANOTHER MANUFACTURER TO CARRY OUT THE OTHER SAMPLES. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. 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 |
|---|---|---|---|---|---|---|---|
| 974747 | PENTAX | VIDEO BRONCHO SCOPE | EOQ | HOYA CORPORATION PENTAX TOKYO OFFICE | EB15-J10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Unknown |