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

Model Number	WA22557C
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to olympus/ the cause of the reported event cannot be determined at this time.Olympus will continue to investigate this complaint to obtain more detailed information regarding the reported complaint.If additional information becomes available or if the device is returned at a later date, this report will be updated and supplemented accordingly.
Event or Problem Description
Olympus was informed that following a therapeutic procedure, the patient was observed to have a labia burn.The intended procedure was completed with the same equipment without issue.Later the same day, the patient called the hospital as the patient was experiencing an unspecified pain.The patient was admitted back to the hospital and the doctor observed a labia burn to the patient.There were no details provided regarding the severity of the burn and how the patient was treated, however, the patient was discharged on the same day.

• Brand Name: HF-RESECTION ELECTRODE, BUTTON, 24-28 FR
• Common Device Name: HF ELECTRODE BUTTON
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 7853507
• Report Number: 2951238-2018-00528
• Device Sequence Number: 11254474
• Product Code: FAS
• UDI-Device Identifier: 14042761068342
• UDI-Public: 14042761068342
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/06/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: WA22557C
• Device Catalogue Number: WA22557C
• 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: 08/17/2018
• Initial Report FDA Received Date: 09/06/2018
• 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: OLYMPUS/GYRUS: GENERATOR (MODEL/SN UNKNOWN)
• Outcome Attributed to Adverse Event: Other; Required Intervention