RESECTION SHEATH, 24 FR.
Report
- Report Number
- 9610773-2023-03305
- Event Type
- Malfunction
- Date Received
- November 15, 2023
- Date of Event
- October 30, 2023
- Report Date
- July 2, 2024
- Manufacturer
- OLYMPUS WINTER & IBE GMBH
- Product Code
- HIH
- UDI-DI
- 04042761020961
- PMA / PMN Number
- K931994
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
G4: K931994/ K931995. THE SUBJECT DEVICE WAS RETURNED TO AN OLYMPUS REPAIR CENTER FOR EVALUATION AND THE CUSTOMER¿S REPORTED ISSUE WAS CONFIRMED. THE DEVICE EVALUATION FOUND CERAMIC TIP, SPRING SHELL AND SEALING RING WAS DAMAGED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 18 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTABLE MALFUNCTION WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION ON CERAMIC TIP: BASED ON THE DAMAGE PATTERN, WE ASSUME THAT THE DAMAGE TO THE INSULATION INSERT WAS INDUCED THERMALLY AND/OR MECHANICALLY. THEREFORE, IT IS MOST LIKELY ATTRIBUTABLE TO WEAR AND TEAR AND/OR IMPROPER HANDLING BY THE CUSTOMER (MORE SPECIFICALLY THE DEVICE BEING SUBJECTED TO MECHANICAL OVERLOAD, IMPACT, ACCIDENTAL DROPPING, ETC.). WE CANNOT DETERMINE IF THERE WAS PRE-EXISTING DAMAGE TO THE INSULATION INSERT OR IF IT WAS ALREADY WORN. FURTHERMORE, IT CANNOT BE DETERMINED IF THE DAMAGE WAS CAUSED DURING THE LAST REPROCESSING OF THE INSTRUMENT OR DURING ITS LAST USE IN A PROCEDURE. AS A GENERAL NOTE, CRACKS ON THE INSULATION MATERIAL ARE MOSTLY NOT VISIBLE, MAKING VISUAL INSPECTION DIFFICULT. LOST FRAGMENTS OF THE CERAMIC INSULATION INSERT CAN BE LOCALIZED AND REMOVED USING A SUITABLE X-RAY PROCEDURE OR COMPUTED TOMOGRAPHY. THE USER MAY DETECT THE EVENT BY HANDLING THE DEVICE ACCORDING TO THE FOLLOWING INSTRUCTION FOR USE (IFU): BEFORE THE USE OF MEDICAL DEVICES, THE USER MUST MAKE SURE THAT THEY ARE IN A PERFECT TECHNICAL CONDITION. INFECTION CONTROL RISK PROPERLY REPROCESS THE PRODUCT BEFORE FIRST AND EACH SUBSEQUENT USE FOLLOWING THE INSTRUCTIONS IN THIS MANUAL AND IN THE SYSTEM GUIDE ENDOSCOPY. IMPROPER AND/OR INCOMPLETE REPROCESSING CAN CAUSE INFECTION OF THE PATIENT AND/OR MEDICAL PERSONNEL. 4.1 INSPECTION AND TESTING INSPECTING THE PRODUCT VISUALLY INSPECT THE PRODUCT. MAKE SURE THAT IT HAS: -- NO CORROSION -- NO DENTS -- NO SCRATCHES CERAMIC INSULATION AT DISTAL END VISUALLY INSPECT THE CERAMIC INSULATION AT THE SHEATH¿S DISTAL END BEFORE EACH USE. DO NOT USE THE INSTRUMENT IN CASE OF DAMAGE (E.G. CRACKS, FRACTURES). WARNING RISK OF INJURY IMPACT, FALL, SHOCK OR SIMILAR STRESS CAN DAMAGE THE CERAMIC INSULATION AT THE SHEATH¿S DISTAL END. DAMAGED INSTRUMENTS CAN CAUSE INJURIES TO THE PATIENT AND/OR USER. DO NOT USE THE INSTRUMENT IF DAMAGED. DAMAGED PRODUCT IF THE PRODUCT IS DAMAGED OR DOES NOT FUNCTION PROPERLY, CONTACT AN OLYMPUS REPRESENTATIVE OR AN AUTHORIZED SERVICE CENTER.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
THE CUSTOMER REPORTED TO OLYMPUS, THE RESECTION SHEATH, 24 FR. HAD A BROKEN CERAMIC TIP. THE ISSUE WAS FOUND DURING REPROCESSING. THE PROCEDURE WAS UNKNOWN. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1152660 | RESECTION SHEATH, 24 FR. | HYSTEROSCOPE (AND ACCESSORIES) | HIH | OLYMPUS WINTER & IBE GMBH | A22041A | 062W-0095 | 04042761020961 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |