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

Model Number 161W-0013

Device Problem Break (1069)

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

Event Date 09/06/2019

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device has not yet been returned to the service center for evaluation.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation or additional significant information becomes available, this report will be updated.

Event Description

The service was informed that the during a therapeutic transurethral resection of the prostate (turp) procedure, the distal end of sheath broke off and fell into the patient.The device fragment was retrieved by flexible graspers.There was no unexpected bleeding.There was no x-ray performed as it was retrieved in its entirety.There was no resistance felt upon insertion.No other equipment was replaced during the procedure.It is unknown if the intended procedure was completed.There was no patient injury reported.Additionally, the user facility reported that the sheath was inspected prior to use by central sterile services department (cssd), before sterilizing and by scrub tech.The sheath was stored in a sterile tray, wrapped and placed on shelf.The storage environment does not have heavy light exposure.

Manufacturer Narrative

The customer returned the a22041a resection sheath for evaluation.The user¿s complaint was confirmed.A visual inspection was performed on the received device and noted approximately 90 percent of the ceramic beak from the distal end was broken off and missing.The broken portion was not returned.There was only tiny portion that is still intact inside the opening of the outer tube from the distal tip area.Additionally, there was evidence of rust was noted inside the opening of the outer tube at the breaking point of the beak.The printed model and lot number on the outer tube is discolored and also dents noted on the outer tube.Based on the evaluation the cause of the damage/broken/missing distal end beak is due to mishandling.

• Brand Name: RESECTION SHEATH, 24 FR.
• Type of Device: RESECTION SHEATH, 24 FR.
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 9161326
• MDR Text Key: 198136719
• Report Number: 9610773-2019-00135
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 161W-0013
• Device Catalogue Number: A22041A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MEDIUM LOOP RESTOSCOPE (MODEL/SN.UNK)
• Patient Age: 85 YR
• Patient Weight: 76