MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 24 FR., INTERMITTENT IRRIGATION

Model Number	A22014A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported the device will be returned for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.Therefore; the root cause of the reported event cannot be determined at this time.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported the ceramic tip from the resection sheath, 24 fr intermittent irrigation broke off intraoperatively during a transurethral resection of a prostate and laser lithotripsy procedure.The fragment was retrieved from the bladder.The entire piece was retrieved without injury to the patient.
Additional Manufacturer Narrative
This supplemental report is submitted to redact report 9610773-2022-00149/mw # (b)(4) as this event was previously reported via 9610773-2022-00093/mw # (b)(4).

• Brand Name: RESECTION SHEATH, 24 FR., INTERMITTENT IRRIGATION
• Common Device Name: RESECTION SHEATH, 24 FR., INTERMITTENT IRRIGATION
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 14184467
• Report Number: 9610773-2022-00149
• Device Sequence Number: 5024843
• Product Code: HIH
• UDI-Device Identifier: 04042761020893
• UDI-Public: 04042761020893
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K931994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A22014A
• Device Catalogue Number: A22014A
• Device Lot Number: AC22028528
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2022
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 05/22/2022
• 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
• Patient Sex: Unknown