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

Model Number A22040A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2021

Event Type  malfunction  

Manufacturer Narrative

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

Olympus became aware via maude medical device database report# 11633468, "doctor was using the olympus tup bipolar and the black plastic piece broke off into the bladder.Surgeon spent extra time on the case to remove piece.Narrative from operative report: as the surgeon was about to cauterize the bleeders, the plastic piece at the end of the visual obturator broke, leaving a fragment in the bladder.This was easily grasped and removed in its entirety with biopsy forceps." no adverse outcome to the patient was reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer and to update the following sections: g3, g6, h2, h6 and h10.The legal manufacturer was unable to perform the review of the device history records for this device as no lot number was not provided and no device was returned.However, the manufacturing and quality control review was performed by the legal manufacturer for the last 24 months of production and there are no 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 probable cause of the reported damage of the insulation material was caused by thermal mechanical overload, improper handling, mechanical impact like fall, shock or similar stress.Please note that signs of fatigue or pre-damage, such as minute cracks, are often hard to spot.As stated on the ifu (instruction for use) and as a preventive measure, the user manual indicates the customer is required to check the function of all devices used prior to a procedure.Additionally, according to the ifu, a suitable replacement device must be provided during an application.The legal manufacturer will continue to monitor the field performance of 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: 12105037
• MDR Text Key: 268146821
• Report Number: 9610773-2021-00187
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761029339
• UDI-Public: 04042761029339
• Combination Product (y/n): N
• PMA/PMN Number: K931994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22040A
• Device Catalogue Number: A22040A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1