MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 24 FR., WITH DEFLECTING OBTURATOR

Model Number	A22041T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of our investigation, olympus followed up with the user facility via telephone and in writing to obtain additional information regarding the reported event but no information was obtained.However, if additional information becomes available or if the device is returned for evaluation, this report will be updated accordingly.The device referenced in this report has not been returned to olympus for evaluation.The exact cause of the reported tip breaking from the distal end of the resection sheath could not be conclusively determined at this time.However, based on similar reported complaints related to the device and the reported event, the potential cause of the reported event can be attributed to added stress/forces applied to the ceramic insulation at the sheath¿s distal end.The instructions manual contains warning statements in effort to prevent damage to the device that states to "visually inspect the sheath's ceramic insulation at the distal end before each use.Do not use the instrument in case of damage (e.G.Cracks, fractures).Impact, fall, shock, or similar stress can result in damages of the ceramic insulation at the sheath's distal end.Damaged instruments can cause injuries of the patient and/or user.Do not use the instrument if damaged.¿.
Event or Problem Description
Olympus was informed that during an unspecified therapeutic procedure, the distal tip of the device partially broke off into multiple pieces inside the patient¿s bladder.The user facility reported they were unable to retrieve all the device fragments, however, there as no patient injury reported.

• Brand Name: RESECTION SHEATH, 24 FR., WITH DEFLECTING OBTURATOR
• Common Device Name: RESECTION SHEATH, 24 FR.
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 8401441
• Report Number: 2951238-2019-00507
• Device Sequence Number: 10840902
• Product Code: FJL
• UDI-Device Identifier: 04042761020978
• UDI-Public: 04042761020978
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K931995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2019

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: A22041T
• Device Catalogue Number: A22041T
• Device Lot Number: 118W-0135
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1