MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH, WITH A22085A

Model Number A22040T

Device Problem Break (1069)

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

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The most likely cause for the reported event is that the insulation tip's fracture was caused by thermal/mechanical influence.Most likely a stress crack developed vertically through the insulation insert leading to the insulation beak completely tearing off.It cannot be determined, whether undiscovered damage already existed prior to the tip breaking.The ifu carries a warning that the ceramic tip can break due to mechanical loading or thermally induced straining.Thus, it is the responsibility of the user to inspect the instrument prior to every procedure.In addition, the oem performed a manufacturing and quality control review for the affected lot number without showing any non-conformities or deviations regarding the described issue.

Event Description

Olympus was informed that during a transurethral vaporization of prostate (tuvp) with the plasma button procedure, pieces from the sheath tip broke off and fell into the patient¿s bladder.It unknown if the device fragments were retrieved.There intended procedure was completed with the same device.There was no patient injury reported.

Manufacturer Narrative

Olympus received additional information that states that previously reported event occurred during a transurethral resection of bladder tumor procedure.The device fragments were retrieved with a stent grasper.There were no issues assembling the device with the other equipment, or operating the device prior to the event.There were no problems with the obturator.The device did not experience any external impact or falls prior to the procedure.Pro advantage lubricating jelly was applied to the device.The device was inspected prior to use and no abnormalities were observed.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation findings, a manufacturing and quality control review was performed for the affected lot number without showing any non-conformities or deviations regarding the described issue.The device was returned to the service center for evaluation.A visual inspection on the received device was performed and found approximately 5mm of the insulation ceramic beak from the distal end broken into 2 small pieces.The outer tube also inspected and noted minor scratches and dents.The cause of the broken ceramic beak pieces is due to excessive force attributed to mishandling.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH, WITH A22085A
• Type of Device: INNER SHEATH, FOR 26 FR.
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 8462765
• MDR Text Key: 141333570
• Report Number: 2951238-2019-00578
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761029360
• UDI-Public: 04042761029360
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2019

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: A22040T
• Device Catalogue Number: A22040T
• Device Lot Number: 16XW-0083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2019
• Initial Date FDA Received: 03/28/2019
• Supplement Dates Manufacturer Received: 04/15/2019; 06/14/2019
• Supplement Dates FDA Received: 05/02/2019; 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OUTER SHEATH: REF# A22026A; WORKING ELEMENT: REF# WA22367A
• Patient Age: 73 YR