MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 24 FR.; HYSTEROSCOPE (AND ACCESSORIES)

Model Number A22041A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urethral Stenosis/Stricture (4501)

Event Type  Injury  

Manufacturer Narrative

The device was returned for evaluation and the customers allegation could not be confirmed.No external abnormalities were found.The sheath, electrode, and reflux sheath were all assembled, and no abnormalities were found.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The patients experienced consecutive urethral strictures after transurethral resection in saline (turis) procedures in which the working element (wa22366a) and 24fr resection sheath (a22041a) were used in combination.The procedure was completed using the same device and no additional medical treatment or surgical intervention was required.The physician opinion is that either the handle or the sheath was the cause.Related patient identifiers: (b)(6) working element, active, for resection in saline (wa22366a / 147w0080).(b)(6) working element, active, for resection in saline (wa22366a / 147w0080).(b)(6) resection sheath, 24 fr.(a22041a / 147w0083).(b)(6) resection sheath, 24 fr.(a22041a / 147w0083).This medwatch is for patient identifier (b)(6).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the subject device meets specification and a specific root cause of the reported event could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: RESECTION SHEATH, 24 FR.
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18219365
• MDR Text Key: 329196601
• Report Number: 9610773-2023-03397
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020961
• UDI-Public: 04042761020961
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K931994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: A22041A
• Device Lot Number: 147W-0083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 02/22/2024
• Supplement Dates FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: WORKING ELEMENT (B)(6) / 147W0080
• Patient Outcome(s): Other