MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 24 FR.; RESECTOSCOPE SHEATH

Model Number A22041A

Device Problem Fracture (1260)

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

Event Type  malfunction  

Manufacturer Narrative

The device evaluation also noted, the tension ring at the proximal end of the sheath is worn.The device history records for the affected lot was reviewed, without showing any non-conformities or deviations regarding the described issue.The device was manufactured according to valid instructions and met all specifications.The root cause of the damaged/fractured ceramic insulation cannot conclusively be determined.However, the most probable causes can be attributed to thermal and/or mechanical fatigue.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.).As a general note, cracks on the insulation material are mostly not visible, making visual inspection difficult.To mitigate the injury to the patient and also device damage, the instruction for use provides the following: 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.Visually inspect the product: make sure that it has no corrosion, no dents, no scratches.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).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: if the product is damaged or does not function properly, contact an olympus representative or an authorized service center.In general, the end-user is required to inspect the device for defects.Check the function of all devices.And have alternate equipment prior to use.Olympus will continue to monitor complaints related to the device and reported phenomenon.Additional 501(k): k931994.

Event Description

The customer inner sheath was returned to the service center for an unspecified repair request.However, during the evaluation, the ceramic insulation at the distal tip of the sheath was found damaged/fractured.No death or injury and no impact to patient or other has been reported.This report was submitted to capture the damaged insulation found during the repair evaluation.

• Brand Name: RESECTION SHEATH, 24 FR.
• Type of Device: RESECTOSCOPE SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16895581
• MDR Text Key: 314858266
• Report Number: 9610773-2023-01255
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020961
• UDI-Public: 04042761020961
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K931995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22041A
• Device Catalogue Number: A22041A
• Device Lot Number: 11ZW-0023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2011
• 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