MAUDE Adverse Event Report: GREATBATCH MEDICAL HALL LARGE LITHIUM BATTERY; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number L3000LG

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

The l3000lg device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the l3000lg device was used during a surgery on (b)(6) 2019 and after the surgery was completed the device was place in a sterilization tray and taken to the sterilization department.At which time the device was found to smoke and be melting.The device was place in the tray with the device contacts making contact with metal instruments.The device was "knocked" out of the tray and the smoking/melting stopped.The device was then disposed of by the facility.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The alleged melted l3000lg is not expected to be returned for evaluation and review.This complaint of melted device is unable to be verified and a root cause cannot be determined.The manufacturing documents from the device history record cannot be reviewed because the serial number is not known.A two-year review of complaint history revealed there has been a total of 11 complaints, regarding 11 devices, for this device family and failure mode.During this same time frame 23,057 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 0.0005.Per the instructions for use, the user is advised the following: warnings: -this equipment is designed for use by medical professionals familiar with the instructions for use.Prior to use, read and follow all warnings, precautions and instructions marked on the product and included in this manual.-do not short circuit battery terminals or allow them to come into contact wiht metal objects.This could cause a shock or burn injury and also damage the battery pack.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: HALL LARGE LITHIUM BATTERY
• Type of Device: BATTERY, REPLACEMENT, RECHARGEABLE
• Manufacturer (Section D): GREATBATCH MEDICAL; calle 5 norte no. 511; ciudad industrial; tijuana, 22444 ; MX 22444
• MDR Report Key: 9457391
• MDR Text Key: 170433751
• Report Number: 1017294-2019-00159
• Device Sequence Number: 1
• Product Code: MOQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: L3000LG
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2020
• Patient Sequence Number: 1