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

Model Number A22040A

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/07/2020

Event Type  malfunction  

Manufacturer Narrative

As part of the investigation, olympus followed up with the customer to obtain additional information including the lot number, but with no results.The referenced sheath was not returned to olympus for evaluation.The root cause of the reported event cannot be determined at this time as the investigation is ongoing.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

During the middle of transurethral resection in the bladder procedure, the ceramic tip at the distal end of the inner sheath broke off and inside the patient's bladder.The surgeon admitted to placing a lot of pressure and torque/ "banging" the distal tip of the resectoscope when trying to break up a bladder stone.The broken tip was not removed and the surgeon was going to perform another procedure to remove the ceramic piece that fell off into the patient.The surgeon reported it was a three hour long procedure.No serious injury, death or infection was reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the customer and to update the following sections: g4, g7, h2, h6 and h10.The legal manufacturer was unable to perform a review of the device history records for this device as no lot number was provided.Instead, the manufacturing and quality control review was performed for the last 24 months of production without showing any non-conformities or deviations regarding the described issue.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.The damage to the insulation insert was most likely caused by 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.Olympus will continue to monitor complaints for this device.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: INNER SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 10755111
• MDR Text Key: 225205813
• Report Number: 9610773-2020-00250
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761029339
• UDI-Public: 04042761029339
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

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: A22040A
• Device Catalogue Number: A22040A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 01/25/2021
• Supplement Dates FDA Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention