MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH

Model Number A22040A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

No device was returned to olympus for evaluation, however, the investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.

Event Description

During a transurethral resection of a prostate procedure, the rigid inner sheath's insulation at the distal tip broke off into the patient.No patient injury was reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the original equipment manufacturer (oem) for mdr# 9610773-2020-00234.The oem performed a device history record review and no abnormality was found.The oem completed the investigation and determined that there was no manufacturing, material or processing related cause for this failure mode.Based on the investigation results, the oem determined the most likely causes are: thermo-mechanical fatigue/wear and tear improper handling by the customer (impact, shock) please note that signs of fatigue or pre-damage, such as minute cracks, are often hard to spot.Additionally, the oem is currently investigating the insulation insert¿s long term stability.Olympus will continue to monitor complaints for this device.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: INNER SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 10631523
• MDR Text Key: 218975922
• Report Number: 9610773-2020-00234
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761029339
• UDI-Public: 04042761029339
• Combination Product (y/n): N
• PMA/PMN Number: K931995
• 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: 12/31/2020

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: A22040A
• Device Catalogue Number: A22040A
• Device Lot Number: 142W-0146
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 10/05/2020
• Supplement Dates Manufacturer Received: 12/03/2020
• Supplement Dates FDA Received: 12/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1