SYMMETRY 20-1415KL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-30 for SYMMETRY 20-1415KL manufactured by Olsen Medical.

Event Text Entries

[134788337] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8288567
• MDR Report Key: 8288567
• Date Received: 2019-01-30
• Date of Report: 2019-01-03
• Date of Event: 2018-11-27
• Report Date: 2019-01-03
• Date Reported to FDA: 2019-01-03
• Date Reported to Mfgr: 2019-01-28
• Date Added to Maude: 2019-01-30
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: SYMMETRY
• Generic Name: APPARATUS, ELECTROSURGICAL
• Product Code: HAM
• Date Received: 2019-01-30
• Catalog Number: 20-1415KL
• Lot Number: 108638
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: OLSEN MEDICAL
• Manufacturer Address: 3230 COMMERCE CENTER PLACE LOUISVILLE KY 40211 US 40211

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-01-30