MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 26 FR.

Model Number	A22042A
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The incident was reported via medwatch report mw5166406.This report has been submitted by the importer under this mdr report number 2429304-2025-00100.The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
During a cystoscopy with clot evacuation and fulguration of bleeding vessels, an olympus obturator was being used when the distal black ceramic tip of the 26 fr inner sheath detached and fell into the patient¿s bladder.The tip was successfully retrieved by the surgeon, and the procedure was completed without further issues.A 22 fr 3-way catheter was inserted and connected to continuous bladder irrigation.The instrument and detached tip were quarantined.No further harm to the patient was reported.

• Brand Name: RESECTION SHEATH, 26 FR.
• Common Device Name: RESECTION SHEATH, 26 FR.
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21580121
• Report Number: 9610773-2025-01973
• Device Sequence Number: 21049794
• Product Code: HIH
• UDI-Device Identifier: 04042761020985
• UDI-Public: 04042761020985
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K931995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/11/2025

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
• Operator of Device: Health Professional
• Device Model Number: A22042A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Unknown
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White