MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF UNIT "ESG-400"; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number WB91051W

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Due diligence is executed for this event.Event date is not known.Supplemental report(s) will be filed as the information becomes available.The device has been returned and a device evaluation completed for it.Upon inspection it was observed that the foot switch was damaged.The device passed full inspection and esd test.The device has slight wear and tear not affecting functionality.There was no delay between the handpiece and foot switch observed.User reported issue was not confirmed.

Event Description

The device was sent in for repair for a delay between the handpiece and foot switch during an unknown procedure, when the issue of damaged foot switch was observed.During the procedure, there were no error messages, alerts, or alarms received.The device was inspected and there was no damage to the device or cord.The connection was secure.There was no adverse impact to the patient.

Manufacturer Narrative

There is more information on the device evaluation.This supplemental report is being submitted to provide this information.The device history record review confirmed that the device was manufactured according to valid instructions and met all specifications.A delay of activating the hand switch via the foot switch is a plausible occurrence.This issue could be caused either by a previous electrical overload of the reed contact, or by a leakage in the glass tube of the reed contact.Such a leakage could have occurred, for example, by an intense impact exerted on the foot switch.This is a known error pattern and can possibly be reversible.Per the instructions for use (ifu), a suitable replacement device must be provided during an application.

• Brand Name: HF UNIT "ESG-400"
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 10296199
• MDR Text Key: 199736724
• Report Number: 9610773-2020-00160
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• PMA/PMN Number: K141225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

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: No Information
• Device Model Number: WB91051W
• Device Catalogue Number: WB91051W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/26/2020
• Initial Date FDA Received: 07/20/2020
• Supplement Dates Manufacturer Received: 11/17/2020
• Supplement Dates FDA Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1