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

Model Number A22041A

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

The subject sheath was returned to the service center.A visual inspection was performed and confirmed the beak at the distal end of the device was broken and detached from the sheath.A small chip, long deep crack on the body, and black marks inside the beak were noted.The remaining portion inside of the beak was still securely glued inside the inner sheath, there were no missing fragments.As stated on the ifu (instruction for use) and as a preventive measure, the user manual states: 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.The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

During an unspecified therapeutic procedure, the 24fr.Resection sheath was withdrawn from the patient but the tip of the sheath was reportedly stayed behind in the bladder and had to be retrieved by the surgeon.No death, serious injury or infection was reported.

Event Description

The clinical nurse manager at the user facility reported, at the end of a cystoscopy, urethral dilation with transurethral resection of the prostate procedure, the 24fr.Resection sheath was withdrawn from the patient but the tip of the sheath reportedly stayed behind in the bladder and had to be retrieved by the surgeon.The surgeon used a rigid biopsy forceps to retrieve the broken tip.There was a delay in the procedure by 20 minutes.The intended procedure was completed.No death, serious injury or infection was reported.Additionally, the patient was under anesthesia.The device was not replaced as it was at the end of the case.There were no devices replaced during the procedure.The device was inspected prior to use by a surgical technician.There was no damage or abnormalities observed.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The following sections were updated: a2, a3, b5, g4, g7, h2, h4, h6 and h10.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the probable cause is likely 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.This issue is addressed in the instructions for use (ifu): "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." olympus will continue to monitor complaints for this device.

• 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: 11094720
• MDR Text Key: 227883529
• Report Number: 9610773-2020-00306
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• 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: 182W-0045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 73