MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT PNCL,PB,UCLN,1"BD,10',HLS,NC,S; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	131309A
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The alleged device will not be returned for evaluation and review.This complaint of arcing/sparking device caused burn/blister is unable to be verified and a root cause cannot be determined.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised the following: safety tips: use lowest possible power setting on the associated electrosurgical unit capable of achieving desired surgical effect.Activation time should be as short as possible.Inspect and test each device before use.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the 131309a device was being used during a mastopexy on (b)(6) 2019.The surgeon stated that blood accumulated at the tip which could have caused an arced/spark causing his gloves to pop.The event caused a 5-minute delay; however, the procedure was completed successfully.The representative was later shown by the surgeon that he had a blister on the first knuckle of the second digit.This report is being raised on the basis of injury due to the burn of unknown degree.

• Brand Name: PNCL,PB,UCLN,1"BD,10',HLS,NC,S
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• MDR Report Key: 8944156
• Report Number: 3007305485-2019-00323
• Device Sequence Number: 11373649
• Product Code: GEI
• UDI-Device Identifier: 30653405056274
• UDI-Public: (01)30653405056274(17)240218(10)201902195
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K791137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/18/2024
• Device Model Number: 131309A
• Device Catalogue Number: 131309A
• Device Lot Number: 201902195
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other