MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT ABC HANDPIECE LAPAROSCOPIC; ARGON HANDPIECE

Catalog Number 160656

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2018

Event Type  malfunction  

Manufacturer Narrative

The report device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported the 130344, single function abc handpiece, caught fire at the tip during a laparoscopic cholecystectomy on "(b)(6)" 2018.The fire was in the sterile field at the time, but it was stomped out by the surgeon.There were no patient or user injuries.The surgical team was familiar with the product due to continuous education by nursing staff.The abc handpiece was stored in the holster in the sterile field when not in use.The handpiece was attached to the 7550 argon generator.The handpiece was checked prior to surgery.It is unknown how long the handpiece was in use before it caught fire.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Correction: previously stated catalog # 130344, lot # 201810294 corrected to catalog # 160656, no lot # provided.Previously stated k871435 corrected to k925903.Two 160656 were received, one in opened unoriginal packaging the other in opened original packaging, the reported catalog number was verified, the lot number was not verified.Visual inspection found that the device that did not have original packaging appeared burnt at the distal end and that the shaft and coating were damaged.The device was also functionally inspected with a system 7500 esu ((b)(4)).Functional inspection found that the argon beam ejected straight from the tip and did not appear to arc or creep along the sides.No smoke, fire, or sparking was observed during testing.The manufacturing documents from the device history record could not be reviewed due to no lot number being provided.(b)(4).Per the instructions for use, the user is advised the following; not to use in the presence of flammable anesthetics, disinfecting agents, oxygen-rich environments or other combustible materials.Before use, inspect the cord insulation and hand piece integrity and condition.If damaged, chipped, cut, or nicked, do not use the hand piece /probe.This issue will continue to be monitored through the complaint system to assure patient safety.

Manufacturer Narrative

Correction: previously stated the date of incident was (b)(6) 2018, the date of incident is actually (b)(6) 2019.This issue will continue to be monitored through the complaint system to assure patient safety.

Manufacturer Narrative

Correction: previously stated the date of incident was (b)(6) 2019, the date of incident is actually (b)(6) 2018.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: ABC HANDPIECE LAPAROSCOPIC
• Type of Device: ARGON HANDPIECE
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: melanie hansen ; 11311 concept boulevard; largo, FL 33773 ; 7273995209
• MDR Report Key: 8349414
• MDR Text Key: 136452819
• Report Number: 3007305485-2019-00033
• Device Sequence Number: 1
• Product Code: HAM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925903
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 160656
• Device Lot Number: 201810294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1