MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, CYLINDER, WITH GROOVES

Model Number	A22257C
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Shock (2072)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The electrode was not returned to the service center for evaluation.As part of our investigation, an olympus sales representative visited the customer's site and observed 5-6 procedures using the facility's new generator and the phenomenon could not be reproduced.The sales representative also stated the generator that was used during the case has since been used but not with a resectoscope electrode.The facility was unsure about which device contributed to the doctor's incident.The cause of the reported event cannot be determined at this time.However, the a22257c ifu instructs users in the ¿inspection and testing¿ section ¿ inspect the instrument.Visually inspect the instrument.Warped electrodes, defective insulation and broken, cracked, or irregular cutting loops represent a danger for both the patient and the surgeon and must not be used.Never try to bend irregular cutting loops into shape!¿ if additional information is received, or the device is returned at a later this report will be supplemented accordingly.
Event or Problem Description
The service center was informed that during unspecified procedure, while using the electrode the doctor felt a shock.There was no treatment required.The intended procedure was completed.There was no effect to the patient.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information received from the original equipment manufacturer (oem).The oem reported that the manufacturing and quality control review was performed for the affected lot or serial number without showing any non-conformities or deviations regarding the described issue.

• Brand Name: HF-RESECTION ELECTRODE, CYLINDER, WITH GROOVES
• Common Device Name: HF-RESECTION ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• MDR Report Key: 8685488
• Report Number: 2951238-2019-00927
• Device Sequence Number: 2268772
• Product Code: GCP
• UDI-Device Identifier: 14042761030448
• UDI-Public: 14042761030448
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

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: A22257C
• Device Catalogue Number: A22257C
• Device Lot Number: 1000032902
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 05/19/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 06/18/2019
• 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: NON OLYMPUS GENERATOR