MAUDE Adverse Event Report: OLSEN MEDICAL SYMMETRY; APPARATUS, ELECTROSURGICAL

Catalog Number 20-1415KL

Device Problem Electrical Shorting (2926)

Patient Problem No Information (3190)

Event Date 11/27/2018

Event Type  malfunction  

Event Description

During surgical spine procedure, the doctor was using a disposable insulated bayonet forceps, and stated that they were not working.It was initially plugged into their preferred unit (codman).Doctor said it seemed it was working, then stopped, working ,stopped.They described the malfunction as a "short circuit-- something's wrong with the connection." action taken by rn, who switched to a different cautery machine ( x2) i switched foot pedals (x 2).Rn opened new bayonet forceps ( x2) i then opened a third and checked it was a new lot number and worked.

• Brand Name: SYMMETRY
• Type of Device: APPARATUS, ELECTROSURGICAL
• Manufacturer (Section D): OLSEN MEDICAL; 3230 commerce center place; louisville KY 40211
• MDR Report Key: 8288567
• MDR Text Key: 134788337
• Report Number: 8288567
• Device Sequence Number: 1
• Product Code: HAM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/03/2019

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: No Information
• Device Catalogue Number: 20-1415KL
• Device Lot Number: 108638
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/03/2019
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 01/28/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21535 DA