MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH NEUTRAL ELECTRODE, FOR ADULTS, WITH CABLE; ELECTROSURGICAL RETURN ELECTRODE, SINGLE-USE

Model Number	WA99514C
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the adult patient had a sunburn-like burn (redness) to an unspecified location of the leg where the subject device was placed, in a straight line.The olympus representative surmises the subject device was not placed properly on the patient and caused a heat buildup.The subject device was not burnt.The therapeutic anal fistula procedure was completed successfully.The subject device was connected to an non-olympus generator with the settings at 50/50 blend coagulation.The settings were high and the non-olympus teflon pad melted too.No alarms went off during the procedure.
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, it is likely that the reported issue (skin burn) was due to improper use of the neutral electrode, such as incorrect placement.In addition, since it is not an olympus product, it is not possible to assess whether the settings of the generator used may have been the cause of the reported issue.Therefore, the root cause could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: NEUTRAL ELECTRODE, FOR ADULTS, WITH CABLE
• Common Device Name: ELECTROSURGICAL RETURN ELECTRODE, SINGLE-USE
• 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: 15126995
• Report Number: 9610773-2022-00303
• Device Sequence Number: 14894659
• Product Code: GEI
• UDI-Device Identifier: 04042761085892
• UDI-Public: 04042761085892
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K173877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

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 Expiration Date: 05/01/2025
• Device Model Number: WA99514C
• Device Catalogue Number: WA99510A
• Device Lot Number: 207-303
• Was Device Available for Evaluation?: No
• 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: 06/29/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NON-OLYMPUS GENERATORNON-OLYMPUS CAUTERY TOOL
• Patient Sex: Unknown