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

Model Number A22041A

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

No device was returned to olympus for evaluation.The cause of the reported event could not be conclusively determined.However, the most likely cause of the reported ceramic tip breakage could be attributed to the operator's technique.The instruction manual states to visually inspect the sheath¿s ceramic insulation at the 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 result in damages of the ceramic insulation at the sheath¿s distal end.Damaged instruments can cause injuries of the patient and/or user.Do not use the instrument if damaged.If additional information becomes available or if the device is returned for evaluation, this report will be updated accordingly.

Event Description

Olympus received a voluntary medwatch report (# mw5083115) which stated that at the end of a transurethral resection of a bladder tumor, the patient was noted to have significant bleeding.The urologist controlled the bleeding by placing a three-way catheter and inflation of a balloon.When the resectoscope was disassembled it was noted that the beak of the device had fractured as a piece was broken off.A search for the device fragment was done in the room including in the trash and specimen, but no device fragment was found.A fluoroscopy was performed but the device fragment was not found in the patient.A decision was made to not perform a cystoscopy to search for the fragment.The bleeding was controlled and a ct scan was performed later that afternoon and radiology confirmed there was no evidence of a retained device fragment in the patient.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the device history record (dhr) review.Update: h6.Manufacturing and quality control review was performed for the affected lot or serial number without showing any non-conformities or deviations regarding the described issue.

• Brand Name: RESECTION SHEATH, 24 FR.
• Type of Device: RESECTION SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 8380734
• MDR Text Key: 139992929
• Report Number: 2951238-2019-00479
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020961
• UDI-Public: 04042761020961
• Combination Product (y/n): N
• PMA/PMN Number: K931995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 03/18/2020

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: A22041A
• Device Catalogue Number: A22041A
• Device Lot Number: 184W-0015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/28/2019
• Supplement Dates Manufacturer Received: 03/18/2019
• Supplement Dates FDA Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1