MAUDE Adverse Event Report: CONMED / LINVATEC CORPORATION D/B/A CONMED LINVATEC CONMED BATTERY; BATTERY, REPLACEMENT, RECHARGEABLE

Model Number L3000

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2019

Event Type  Injury  

Event Description

Conmed batteries stopped working during case.Fda safety report id# (b)(4).

• Brand Name: CONMED BATTERY
• Type of Device: BATTERY, REPLACEMENT, RECHARGEABLE
• Manufacturer (Section D): CONMED / LINVATEC CORPORATION D/B/A CONMED LINVATEC ; largo FL
• MDR Report Key: 9260370
• MDR Text Key: 164830168
• Report Number: MW5090780
• Device Sequence Number: 1
• Product Code: MOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L3000
• Device Catalogue Number: L3000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR