MAUDE Adverse Event Report: CONMED SMALL 12 VOLT NIMH BATTERY PACK

Catalog Number	PRO3520
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	12/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported device has not been returned to conmed for evaluation.Photographs verify the alleged damage; however, a root cause cannot be determined.An investigation has been initiated to assess risk and determine potential root causes.A review of the manufacturing documents has verified the devices were 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 that would contribute to this issue.No prior complaints have been received for this specific lot of 12 units.A two-year historical complaint review revealed no prior similar events for this product.In that same timeframe, (b)(4).The instructions for use advise the user that certain cleaners, presoak sprays or similar products available on the market that are designed to remove organic soils are known to react negatively with plastic and/or metal.Therefore, it is recommended that if any of these products are used in the processing of conmed linvatec shrouds or battery cases, these items must be thoroughly rinsed under running water for a minimum of 10 seconds to remove all residue before sterilization.Failure to do so may result in degradation of the plastic and/or metal of these items causing premature cracking or breaking.This incident type will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported a battery exploded in their sales representatives hand in turkey.This "explosion" was reported to have caused the sales representative to loose vision for approximately 20-25 minutes.His hand was not burned nor was a physical shock delivered from the device.This "explosion" took place in the supply room when the sales representative removed the battery from the charge platform to bring it into the or.This report is raised on the basis of a reported injury.

• Brand Name: SMALL 12 VOLT NIMH BATTERY PACK
• Common Device Name: BATTERY
• Manufacturer (Section D): CONMED; 11311 concept blvd; largo FL 33773
• MDR Report Key: 7163470
• Report Number: 1017294-2017-00147
• Device Sequence Number: 63204
• Product Code: MOQ
• UDI-Device Identifier: 10845854012918
• UDI-Public: (01)10845854012918(11)170919(30)1
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/04/2018

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?: Yes
• Operator of Device: No Information
• Device Catalogue Number: PRO3520
• Device Lot Number: LAA23675
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 01/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1