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

Model Number A22041A

Device Problem Material Separation (1562)

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

Event Date 06/11/2021

Event Type  malfunction  

Manufacturer Narrative

Additional 510(k) - k931995.The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user report was confirmed, the ceramic tip was broken.If additional information becomes available following device evaluation, a supplemental report will be filed.

Event Description

It was reported, the olympus resection sheath's inner liner separated during use and fell inside the patient.According to the initial reporter, they were able to retrieve the segmented portion.There was no patient harm or consequence reported as a result of this event.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.A review of the device history record (dhr), as well as a trending analysis were conducted during this investigation.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.Based on the damage pattern, it is believed that the damage to the insulation insert was induced mechanically.It could not be determined if there was pre-existing damage to the insulation insert or if it was already worn.Furthermore, it could not be determined if the damage was caused during the last reprocessing of the instrument or during its last use in a procedure.As a result of the above, investigation has concluded that wear and tear and/or improper handling by the customer caused the reported failure.Olympus will continue to monitor the field performance of this device.

• Brand Name: RESECTION SHEATH, 24 FR.
• Type of Device: SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 12110006
• MDR Text Key: 280582287
• Report Number: 8010047-2021-08353
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020961
• UDI-Public: 04042761020961
• Combination Product (y/n): N
• PMA/PMN Number: K931994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• 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: 20908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1