MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT UNIVERSAL PLUS MULTIFUNCTION INSTRUMENT - STRAIGHT

Catalog Number	60-6010-003
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received one 60-6010-003 in opened original packaging.Lot number was verified.Performed a visual inspection of the device, there is fluid present in the handle as well as corrosion by the wire connectors.Performed a functional inspection using the esu 7550 (c8406), the complaint could not be replicated.The device functioned as intended.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 were 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.A two-year review of complaint history revealed there has been 7 complaints regarding 7 devices for this device 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, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following; if during suction/ irrigation a leak is noted at the instrument connection, make sure that instrument is properly seated into the handle and the nut is fully tightened.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
Conmed (b)(4) reported on behalf of the facility that the 60-6010-003, universal plus straight button hand piece, auto-activated during a procedure on (b)(6) 2019.A request for additional information has been made, however to date, no new information has been provided.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

• Brand Name: UNIVERSAL PLUS MULTIFUNCTION INSTRUMENT - STRAIGHT
• Common Device Name: UNIVERSAL PLUS MULTIFUNCTION INSTRUMENT
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; 31136 ; MX 31136
• MDR Report Key: 9417983
• Report Number: 3007305485-2019-00404
• Device Sequence Number: 16811743
• Product Code: GEI
• UDI-Device Identifier: 00653405011722
• UDI-Public: (01)00653405011722(17)230314(30)1(10)201803145
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954056
• 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): 12/05/2019

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: 03/14/2023
• Device Catalogue Number: 60-6010-003
• Device Lot Number: 201803154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1