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 Type  malfunction  

Manufacturer Narrative

The referenced inner sheath was returned to olympus for evaluation.A visual inspection on the as is received condition of the device; noted that the ceramic tip located on the distal end was damaged and mostly missing.The remaining portion that was still intact on the inner sheath had sharp edges.Minor dents were observed on the inner sheath near the distal end.The locking mechanism on the inner sheath was properly working and the seal ring had no physical damage.To mitigate the risk of device damage, the instructions for use manual states, ¿impact, fall, shock or similar stress can damage the ceramic insulation at the sheath¿s distal end¿.The root cause of the reported event could not be determined at this time as the investigation is ongoing, however, if additional information becomes available this report will be supplemented accordingly.

Event Description

During procedure, the ceramic tip at the distal end of the inner sheath broke off inside the patient's bladder.The surgeon irrigated the broken tip out of the patient.The procedure was already completed when the event occurred.No patient injury was reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer for mdr# 9610773-2020-00244.The legal manufacturer performed the device history records for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.The legal manufacturer determined the damage to the insulation insert was most likely caused by thermo-mechanical fatigue/wear and tear.Another possible cause is improper handling by the customer, more specifically the device being subjected to mechanical overload, impact, accidental dropping, etc.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, hamburg 22045 ; GM 22045
• MDR Report Key: 10726683
• MDR Text Key: 222553744
• Report Number: 9610773-2020-00244
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• 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: 149W-0119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1