MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS; RESECTOSCOPE SHEATH

Model Number A42011A

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2024

Event Type  Injury  

Manufacturer Narrative

The device was returned and during the evaluation the ceramic tip was broken; therefore, the users claim was duplicated.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported the ceramic tip broke off into patient.A 45 minute delay was reported to retrieve the broken tip.There was the possibility that the procedure would be converted to an open procedure to retrieve the broken ceramic tip.Initially the surgeon believed a part may still be in patient.The procedure was completed.Later it was confirmed the tip was retrieved with an olympus grasper fg-253sx.The doctor believes there is no part of the tip remaining in the patient.No other procedure or medical interventions were required.The patients health status is good.

Manufacturer Narrative

This report is being supplemented to provide additional information, based on the legal manufacturer's final investigation and device evaluation.The device was evaluated by olympus.And it was confirmed, that the ceramic tip is broken.Additionally, there were non-reportable (non-pae) defects noted.A review of the device history record found no deviations, that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely, the reported event occurred, due to wear and tear, wrong handling or cracks in the insulation material.Which are not visible in most cases.Additionally, it is possibly caused by the impact of a major mechanical force, e.G.A blow or a fall.Based on the nature of the damage, it is assumed, that this is a thermo-mechanically induced damage.It is unclear, whether the insulation insert had a previous damage or wear and tear through reprocessing or from the last procedure.Furthermore, fragments of the ceramic isolation inlet will usually be removed by the surgeon, during the procedure.If the fragments are not found, they can be located using x-ray or ct scanning and are subsequently removed.The root cause of the reported event could not be determined.The event can be detected/prevented, by following the instructions for use, which state: warning 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".Olympus will continue to monitor field performance for this device.

• Brand Name: RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS
• Type of Device: RESECTOSCOPE SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18783841
• MDR Text Key: 336261632
• Report Number: 9610773-2024-00538
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761023658
• UDI-Public: 04042761023658
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K931994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A42011A
• Device Lot Number: 20116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: GRASPER FG-253SX.
• Patient Outcome(s): Required Intervention