MAUDE Adverse Event Report: COVIDIEN LP LIGASURE IMPACT; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number LF4418

Device Problems Defective Component (2292); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 04/05/2022

Event Type  malfunction  

Event Description

It's not working, when plugged in, it shows " instrument not detected." manufacturer response for ligasure impact, (brand not provided) (per site reporter) issued mprx#: (b)(4), and sent return kit fedex trk# (b)(4).

• Brand Name: LIGASURE IMPACT
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 15347221
• MDR Text Key: 299152187
• Report Number: 15347221
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/25/2022

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
• Device Operator: Health Professional
• Device Model Number: LF4418
• Device Catalogue Number: LF4418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/25/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16060 DA
• Patient Sex: Female