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

Model Number	A22251C
Medical Device Problem Code	Unclear Information (4052)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The referenced device will not be returned to olympus for a physical evaluation as the user facility discarded the device following the procedure.The cause of the reported event cannot be conclusively determined at this time.However, details regarding the patient and procedure are still being investigated.If additional information becomes available or if the device is returned for evaluation, this report will be supplemented accordingly.
Event or Problem Description
Olympus was informed that a patient sustained burn to the perineum during a hysteroscopic ablation procedure.However, it was further reported that the burn was noted after the procedure.No additional information has been reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to correct type of report of the initial 30-day mdr, as the report was erroneously submitted as a 5 day report, thus olympus is not required to initiate action to prevent an unreasonable risk of substantial harm.

• Brand Name: HF-RESECTION ELECTRODE, ROLLER, 24-28 FR
• Common Device Name: HF RESECNTION ELECTRODE, ROLLER
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• MDR Report Key: 7684129
• Report Number: 2951238-2018-00403
• Device Sequence Number: 11112169
• Product Code: GCP
• UDI-Device Identifier: 14042761036815
• UDI-Public: 14042761036815
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A22251C
• Device Lot Number: P1710004
• 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: 07/05/2018
• Supplement Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 07/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other