MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY 6" BEND-A-BEAM MALABLE ABC HP; ABC HANDPIECES

Catalog Number	134006
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The used device was returned for evaluation with its original opened packaging.Device catalog and lot numbers were verified.Visual evaluation found the device's distal insulation, adjacent to the electrode, melted and damaged; potentially caused by the flame occurring at the distal end as described in the incident description.However, when functionally tested, the device was observed to activate and function normally.Flaming of the tip or combustion was not observed.A review of the manufacturing documents verified the device was produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture.There have been no prior similar reports for the lot number of this device.A historical review of complaint data revealed a total of (b)(4) similar complaints involving (b)(4) devices of which (b)(4) were confirmed.(b)(4).A risk analysis was performed and found this failure mode and occurrence level to be acceptable and consistent with current risk documents.The instructions for use advise the user of the following.Prolonged use of the handpiece causes the tip to become very hot and the tip remains hot for a period after use.Do not allow the tip to come in contact with the patient or others after activation to avoid burns.Always place handpiece in a safe insulated location when not in use, to avoid burns.Use lowest possible power setting on the conmed abc® electrosurgical generator capable of achieving the desired surgical effect.Use shortest effective abc® activation time necessary.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The user facility reported that during an extensive gynecology procedure, a bend-a-beam that was in use caught fire at the distal tip of the handpiece.This event occurred near the end of the procedure, and prior to this incident there were no issues with the device.A new handpiece was used to finish the procedure with no reported procedural delays.No patient injury reported.This report is raised on the basis of a reported malfunction with potential for injury with reoccurrence.

• Brand Name: 6" BEND-A-BEAM MALABLE ABC HP
• Common Device Name: ABC HANDPIECES
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas no. 11321; complejo industrial chihuahua; chihuahua, CP 11 36; MX CP 1136
• MDR Report Key: 6911594
• Report Number: 3007305485-2017-00216
• Device Sequence Number: 633730
• Product Code: GEI
• UDI-Device Identifier: 00653405002751
• UDI-Public: (01)00653405002751(17)211211(10)201612124
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K961505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/11/2021
• Device Catalogue Number: 134006
• Device Lot Number: 201612124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 79