MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS

Model Number A42011A

Device Problem Break (1069)

Patient Problem Blood Loss (2597)

Event Date 06/19/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the manufacturer, therefore, the cause of the reported event could not be confirmed.However, if the device is returned at a later date, a supplemental report will be submitted accordingly.The original equipment manufacture (oem) conducted a dhr review for the concerned lot and indicated there were no deviations or non-conformities during production.The device was manufactured in january 2019.As a preventive measure, the instruction manual states, before use - to make the product has been properly reprocessed, inspected and tested.Visually inspect the ceramic insulation at the sheath¿s distal end before each use.Do not use the instrument in case of damage (e.G.Cracks, fractures).In addition, "impact, fall, shock or similar stress can damage the ceramic insulation at the sheath¿s distal end.Damaged instruments can cause injuries to the patient and/or user.Do not use the instrument if damaged.".

Event Description

The manufacturer was informed that during a transurethral resection of the prostate/bladder tumor (turp/turbt), the doctor was performing a standard resection technique, when the tip of the device broke off and fell into the patient's bladder.The device fragments were retrieved by using optical grasping forceps.The resection set was replaced and the intended procedure was completed with a new resection set.The reported event prolonged the procedure by 30 minutes while patient was in spinal requiring additional anesthesia and resulted in some mild bleeding.The user facility reported that it was not as concerning since it was the prostatic urethra.Additionally, the user facility reportedly changed their reprocessing methods for these devices types to machine wash (like a dishwasher) followed by steam cycle.Hand washing and followed by sterrad sterilization was done previously.

Manufacturer Narrative

This supplemental report was submitted to provide additional information to mdr# 9610773-2019-00081.The device was returned to olympus service center for evaluation.A visual inspection was performed and confirmed that the distal end of the ceramic insulation tip was broken.There was a minor dent on the device.The customer returned the broken ceramic tip with a hairline crack on the tip.Most of the broken ceramic tip was returned however it was unknown if all the pieces were recovered and returned.There was a small portion of the ceramic tip that was still on the distal end of the device which was producing a sharp edge.As per ifu under one of the warnings states ¿impact, fall, shock or similar stress can damage the ceramic insulation at the sheath¿s distal end¿.The device was forwarded to the original equipment manufacturer (oem) for further investigation.Initially, the product was announced with lot number 191w.However, the product received was lot number 18zw-0116.Therefore, the lot number in the complaint has been corrected accordingly.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 product was sold most recently on (b)(6) 2019.The investigation was completed by the original equipment manufacturer (oem) and determined that there is no manufacturing, material or processing related cause for this failure mode.The potential root cause has been determined to be due to thermo-mechanical fatigue.Another possible cause is mechanical overload, impact, accidental dropping, etc.As a general note, cracks on the insulation material are mostly not visible, making visual inspection difficult.Olympus will continue to monitor the field performance of this device.

• Brand Name: RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS
• Type of Device: RESECTION SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 8803971
• MDR Text Key: 151870583
• Report Number: 9610773-2019-00081
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761023658
• UDI-Public: 04042761023658
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A42011A
• Device Catalogue Number: A42011A
• Device Lot Number: 191W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/19/2019
• Initial Date FDA Received: 07/18/2019
• Supplement Dates Manufacturer Received: 09/11/2020
• Supplement Dates FDA Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention