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

Model Number A22257C

Device Problem Unintended Electrical Shock (4018)

Patient Problem Shock (2072)

Event Date 05/09/2019

Event Type  malfunction  

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 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.

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
• Type of Device: HF-RESECTION ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• MDR Report Key: 8685488
• MDR Text Key: 147869747
• Report Number: 2951238-2019-00927
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 14042761030448
• UDI-Public: 14042761030448
• Combination Product (y/n): N
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 06/10/2019
• Supplement Dates Manufacturer Received: 05/19/2019
• Supplement Dates FDA Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NON OLYMPUS GENERATOR