MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, BUTTON, 24-28 FR.; HF RESECTION ELECTRODE, BUTTON

Model Number	WA22557C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation at this time.In addition, insufficient information regarding the patient, procedure and device was provided by the user facility.However, if additional information becomes available or if the device is returned at a later date, this report will be supplemented accordingly.The exact cause of the event could not be confirmed at this time.However, based on similar reported events the reported event can occur from mechanical overload by the application of excessive force and improper handling/off-label use, when the electrode comes into contact (unintended) with other metal parts, e.G.Surgical instruments while the high-frequency output was activated, and/or with higher output settings on the electrosurgical generator.The oem performed a dhr review for the concerned lot number without showing any non-conformities or deviations during the manufacturing process.
Event or Problem Description
Olympus was informed that during an unspecified hf resection procedure, the button at the distal end of the device broke off and fell into the patient¿s bladder.The physician retrieved the broken piece from the patient.

• Brand Name: HF-RESECTION ELECTRODE, BUTTON, 24-28 FR.
• Common Device Name: HF RESECTION ELECTRODE, BUTTON
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 7756684
• Report Number: 2951238-2018-00445
• Device Sequence Number: 2217771
• Product Code: FAS
• UDI-Device Identifier: 14042761068342
• UDI-Public: 14042761068342
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K100275
• 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): 08/07/2018

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: WA22557C
• Device Catalogue Number: WA22557C
• Device Lot Number: 1000019926
• 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: 07/10/2018
• Initial Report FDA Received Date: 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1