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

Model Number A22041A

Device Problem Break (1069)

Patient Problems Patient Problem/Medical Problem (2688); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned for evaluation, therefore, the root cause of the reported malfunction cannot be determined at this time.However, the investigation is ongoing; if additional information becomes available or if the device is returned at a later date, this report will be supplemented accordingly.

Event Description

During an unspecified therapeutic procedure, the tip of the 24fr.Resection sheath broke off inside the patient.The physician was able to retrieve the broken piece from the patient.No death, serious injury or infection was reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the cutomer and to update the following sections: a2, a3, a4, b3, g4, g7, h2, h6 and h10.The clinical nurse manager at the user facility further reported the event occurred at the end of therapeutic cystoscopy, urethral dilation, and transurethral resection of bladder tumor procedure.The procedure was delayed it by 20 minutes to remove the broken piece that broke off.Only one piece broke off and was retrieved with no injury.A cystoscope and camera were in use so they were able to see the bladder to remove the piece.The patient was under anesthesia and the procedure was completed.No other devices were replaced, and the device was returned to olympus.The likely cause of the distal tip breaking off was anticipated; repeated sterilizations.The patient did not require an additional length in stay.The device was inspected prior to use and the tip was intact and not loose.The investigation is ongoing; however, if additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.Based on the results of the legal manufacturer's investigation, the damage to the insulation insert was most likely caused by mechanical fatigue.Another possible cause is improper handling by the customer, more specifically the device being subjected to mechanical overload, impact, and/or accidental dropping.

• 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: 11130740
• MDR Text Key: 234504488
• Report Number: 9610773-2021-00041
• 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,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 97 YR
• Patient Weight: 68