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

Model Number A22041A

Device Problem Mechanical Problem (1384)

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

Event Date 04/23/2023

Event Type  malfunction  

Manufacturer Narrative

The device history records for the affected lot number was reviewed without showing any non-conformities or deviations regarding the described issue.The subject device was returned for evaluation and the customer¿s reported problem was confirmed.The ceramic insulation at the distal tip of the device was found loose and worn.The inspection also noted the following (non-reportable) defects, the guide screw is worn/corroded, the tension ring is loose/worn, the sealing ring is worn.The device has not been repaired in the past year.The root cause of the loose and worn ceramic insulation at the distal tip of the sheath cannot conclusively be determined.However, the most likely causes are due to: thermally and/or mechanically fatigue, wear and tear, improper handling (more specifically the device being subjected to mechanical overload, impact, accidental dropping, etc.).The subject device within this report was manufactured prior to a design change that was implemented to prevent reoccurrence.To mitigate damage to the device and patient injury, 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 510(k): k931995.

Event Description

The customer reported that during reprocessing, the ceramic insulation at the distal tip of the resection sheath was found loose.It was reported that the facility completed the scheduled procedure with another sheath without delay.No death or injury and no impact to patient or other has been reported.

• 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: 16981275
• MDR Text Key: 315936067
• Report Number: 9610773-2023-01387
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020961
• UDI-Public: 04042761020961
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K931994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• 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: 105W-0108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2010
• 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