MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LIGASURE IMPACT; ELECTROSURGICAL, CUTTING, COAGULATION

Model Number LF4318

Device Problem Failure to Sense (1559)

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

Event Date 05/02/2019

Event Type  malfunction  

Event Description

Prior to use, the device was tested.The ligature impact was plugged into the f10 and was not recognized by machine.Another ligature impact was obtained and plugged in.The case continued without incident.

• Brand Name: LIGASURE IMPACT
• Type of Device: ELECTROSURGICAL, CUTTING, COAGULATION
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; 1810 w. drake dr.; tempe AZ 85283
• MDR Report Key: 8757773
• MDR Text Key: 149933386
• Report Number: 8757773
• Device Sequence Number: 1
• Product Code: NUJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/17/2019

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
• Device Operator: No Information
• Device Model Number: LF4318
• Device Catalogue Number: LF4318
• Device Lot Number: 7454018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/17/2019
• Date Report to Manufacturer: 07/03/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31755 DA