MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OUTER SHEATH, 26 FR., 2 STOPCOCKS, ROTATABLE

Model Number	A22026A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tissue Damage (2104)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The referenced device was not returned to the manufacturer; therefore, the exact cause of the reported event cannot be confirmed.As part of our investigation, multiple follow ups were made to the user facility to obtain additional information regarding the reported event but no information was obtained.However, based on the reported information, improper maintenance cannot be ruled out as a contributory factor to the reported event.Manufacturing and quality control review was performed for the 24 months due to missing lot numbers without showing any non-conformities or deviations regarding the described issue if additional information becomes available or if the device is returned at a later date, this report will be supplemented accordingly.
Event or Problem Description
The manufacturer was informed by the doctor at the user facility that the connection where the hf resection inner and outer sheath meet (a22040a and a22026a) has the potential to tear the urethra of the patients.The doctor reported that the event has happened before but the doctor did not provide additional information regarding the event or patient.Additionally, the doctor reported that they believe it is one resectoscope set of sheaths that caused the reported event.The user facility utilizes 3rd party repairs for their equipment.This is 2 of 2 devices.

• Brand Name: OUTER SHEATH, 26 FR., 2 STOPCOCKS, ROTATABLE
• Common Device Name: OUTER SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 8804648
• Report Number: 9610773-2019-00083
• Device Sequence Number: 16223234
• Product Code: GCP
• UDI-Device Identifier: 04042761029346
• UDI-Public: 04042761029346
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2019

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: A22026A
• Device Catalogue Number: A22026A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INNER SHEATH:OLYMPUS A22040A, LOT UNKNOWN
• Outcome Attributed to Adverse Event: Other