MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT 6" BEND-A-BEAM MALABLE ABC HANDPIECE

Catalog Number	134006
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation however the provided photographic evidence exhibits the reported failure.The manufacturing documents of the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the last two years.A two-year review of complaint history revealed there has been 5 complaints, regarding 5 devices, for this family and failure mode.During the same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following; these devices should be inspected before use.Visually examine the devices for obvious physical damage such as cracks, broken or distorted parts and broken or significantly bent handle, shaft or connector contacts and to not use if found.Do not bend the malleable shaft more than 60 degrees and to not bend in the no-bend area.Do not bend shaft repeatedly.Bend gently using only the thumb and forefinger.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that during surgery on (b)(6) 2018 the tip of the argon beam handpiece warped, and part of the tip broke off.The tip was very small and could have easily fell into the patient.When the tip broke a sharp pointy needle was exposed.There was no reported injury or delay of surgery.Further attempts to gather information were made but nothing additional other than a device number and lot number could be provided.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

• Brand Name: 6" BEND-A-BEAM MALABLE ABC HANDPIECE
• Common Device Name: ABC HANDPIECE
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• MDR Report Key: 8227292
• Report Number: 3007305485-2018-00319
• Device Sequence Number: 1997680
• Product Code: GEI
• UDI-Device Identifier: 00653405002751
• UDI-Public: (01)00653405002751(17)230305(10)201803064
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K961505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/08/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/05/2023
• Device Catalogue Number: 134006
• Device Lot Number: 201803064
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 01/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1