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

Model Number A22040A

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017); Expiration Date Error (2528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the service center for evaluation.Therefore, the exact cause of the reported event cannot be determined nor the exact expiration of the device.Upon receipt of the device, an evaluation will be performed and a supplemental report will be submitted.

Event Description

The service center received a report of a ceramic tip of the distal end to a resection sheath (a22040a), lot number unknown, that broke off during an unspecified procedure into a patient's bladder.It was reported the device was over five years of age at the time of use during the procedure, and it is not known if the device was inspected prior to use.The surgeon was able to retrieve the ceramic item in two pieces from the bladder successfully, and it was reported no other items remained inside the patient.It was not reported if the intended procedure was completed and the outcome of the patient.

Manufacturer Narrative

This supplemental report is being submitted to provide the device history review (dhr).A device history review of the manufacturing records was performed and no non-conformities or deviations were reported to the related reported incident.The resectoscope sheath (model a22040a), lot number 128w, was not returned to the service center for evaluation of the ceramic tip breaking into two pieces.Therefore, an exact cause could not be determined for the broken distal tip.An investigation for this failure mode has been opened, if additional information becomes available a supplemental report will be filed.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: RESECTOSCOPE SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 9621889
• MDR Text Key: 198146550
• Report Number: 9610773-2020-00049
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• 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: 128W
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1