PENTAX
Report
- Report Number
- 2518897-2024-00002
- Event Type
- Injury
- Date Received
- January 29, 2024
- Date of Event
- May 10, 2023
- Report Date
- February 28, 2024
- Manufacturer
- HOYA CORPORATION PENTAX TOKYO OFFICE
- Product Code
- FDF
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
F10 CONTINUED: INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING HEALTH EFFECT CLINICAL CODE: 2668 BOWEL PERFORATION HEALTH EFFECT IMPACT CODE: 4648 INSUFFICIENT INFORMATION MEDICAL DEVICE PROBLEM CODE: 1091 DEVICE REPROCESSING PROBLEM, 3026 UNINTENDED MOVEMENT COMPONENT CODE: 527 VALVE(S), 943 RING. ________________ F10 CONTINUED: INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING HEALTH EFFECT IMPACT CODE: REMOVED 4648 INSUFFICIENT INFORMATION, ADDED 2368 SEDATION, 4641 UNEXPECTED MEDICAL INTERVENTION COMPONENT CODE: ADDED 525 TUBE. ________________ EVALUATION SUMMARY PENTAX MEDICAL EMEA RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM (B)(6) HOSPITAL ON (B)(6) 2024. PATIENT01: OCCURRENCE DATE: (B)(6) 2022 PATIENT'S HISTORY: DIVERTICULOSIS WITH STENOSIS FORMATION IN SIGMOID PLACE PERFORATION: COECUM; LONGITUDINAL TEAR; DIDN'T GO TO COECUM WITH A SCOOP SEDATION: DORMICUM AND FENTANYL PATIENT DAMAGE:DIED AFTER LAPAROSCOPY AND LAPAROTOMY. PATIENT02: OCCURRENCE DATE: (B)(6) 2023 PATIENT'S HISTORY: POSITIVE TEST VIA BVO; CT COLONOGRAPHY WITH POSSIBLE SUSPICION OF TUMOR/DIVERTICULITIS PLACE PERFORATION: DISTAL TRANSVERSE; 2 LENGTH TEARS, EXTRALUMINAL SEDATION: PROPOFOL PATIENT DAMAGE: LAPAROSCOPY WITH STOMA. PATIENT03: OCCURRENCE DATE: (B)(6) 2023 PATIENT'S HISTORY: DIVERTICULITIS OF THE SIGMOID PLACE PERFORATION: COECUM; DIDN'T GO TO COECUM WITH A SCOOP SEDATION: PROPOFOL PATIENT DAMAGE: LAPAROSCOPY AND DOUGLAS FIR ABSCESS. PATIENT04: OCCURRENCE DATE: (B)(6)2023 PATIENT'S HISTORY: POSITIVE TEST VIA BVO; PLACE PERFORATION: COECUM; 2 POLYPS REMOVED 'COLD' COECUM; HOLE SEDATION: PROPOFOL PATIENT DAMAGE: LAPAROTOMY. RESULTS OF THE INVESTIGATION THAT MAINTENANCE, CLEANING AND DISINFECTION WERE NOT DONE ACCORDING TO INSTRUCTIONS FOR USE AND VISIBLY FAULTY VALVES WERE NOT REMOVED FROM CIRCULATION. THERE WERE NO DEFECTS WITH THE ENDOSCOPE. A DEVICE HISTORY RECORD(DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED BY PENTAX MEDICAL MIYAGI ON 03-DEC-2020 UNDER NORMAL CONDITIONS. THE ENDOSCOPE WAS REWORKED FOR FILTER REPLACEMENT INCLUDING FILTER DEFECT AND PASSED REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED FOR 03-DEC-2020. 2518897-2024-00001_EC38-I10F2_(B)(6)_PATIENT PROCEDURE 01. 2518897-2024-00002_EC34-I10TF_(B)(6)_PATIENT PROCEDURE 02. 2518897-2024-00003_EC38-I10F2_(B)(6)_PATIENT PROCEDURE 03. 2518897-2024-00008_EC38-I10F2_(B)(6)_PATIENT PROCEDURE 04. 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: 2668 BOWEL PERFORATION. HEALTH EFFECT IMPACT CODE: 4648 INSUFFICIENT INFORMATION. MEDICAL DEVICE PROBLEM CODE: 1091 DEVICE REPROCESSING PROBLEM, 3026 UNINTENDED MOVEMENT. COMPONENT CODE: 527 VALVE(S), 943 RING. ________________ THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES. PENTAX MEDICAL EMEA PERFORMED GOOD FAITH EFFORTS TO GATHER ADDITIONAL INFORMATION REGARDING THE PATIENT'S MEDICAL INTERVENTIONS AND PATIENT OUTCOMES, BUT NO INFORMATION IS AVAILABLE AT THIS TIME. THE CURRENT INVESTIGATION IS AS FOLLOWS. - THERE IS PROBABLY A BURR IN THE VALVE SEAT OF THE VALVES. - BURRS IN THE VALVE SEAT CAN DAMAGE THE VALVE O-RINGS. - WATER CAN FLOW UNCONTROLLABLY THROUGH THE DEFECTIVE O-RINGS. INVESTIGATION IS IN-PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. FILE ATTACHMENTS. 2518897-2024-00001_EC38-I10F2_(B)(6)_PATIENT PROCEDURE 01. 2518897-2024-00002_EC34-I10TF_(B)(6)_PATIENT PROCEDURE 02. 2518897-2024-00003_EC38-I10F2_(B)(6)_PATIENT PROCEDURE 03.
REFER TO H10.
ON 04-JAN-2024 THE HEALTH AND YOUTH CARE INSPECTORATE, THE COMPETENT AUTHORITY REGARDING MEDICAL DEVICES IN THE NETHERLANDS, NOTIFIED PENTAX MEDICAL THE INSPECTORATE HAD BECOME AWARE OF SEVERAL SERIOUS INCIDENTS IN THE NETHERLANDS INVOLVING PENTAX ENDOSCOPES DURING USE. THE USER FACILITY REPORTED THAT SEVERAL PENTAX ENDOSCOPE PERFORATIONS OCCURRED. ROOTCAUSE ANALYSIS CONCLUSIONS BY THE HOSPITAL; THE PERFORATIONS ARE LIKELY DUE TO IMPROPERLY FUNCTIONING VALVES. THE HEALTHCARE FACILITY ANALYSIS REVEALED THAT MAINTENANCE, CLEANING AND DISINFECTION WERE NOT DONE ACCORDING TO INSTRUCTIONS FOR USE. THE ANALYSIS ALSO REVEALED THAT THIS FACILITY CONTINUED TO USE A FAULTY VALVE FOR ENDOSCOPY, EVEN THOUGH THIS FAULT OF VALVE WAS VISIBLY DETECTED. ADDITIONALLY, THE ANALYSIS ALSO CONCLUDES THAT THE PROBABLE ROOT CAUSE IS USER ERROR, RATHER THAN A MEDICAL DEVICE DEFECT. 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 |
|---|---|---|---|---|---|---|---|
| 1250349 | PENTAX | VIDEO COLONOSCOPE | FDF | HOYA CORPORATION PENTAX TOKYO OFFICE | EC34-I10TF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| O |