MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDERS; ELECTROSURGICAL, CUTTING & COAG, LAP & ENDOSCOPIC, REPROCESSED

Catalog Number LF1637

Device Problems Difficult to Open or Close (2921); Physical Resistance/Sticking (4012)

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

Event Date 05/01/2019

Event Type  malfunction  

Event Description

Ligasure blunt tip laparoscopic sealer/divider malfunctioned by grasper unable to close after in the open position as grasper head began to disassemble.No parts seen in abdomen or noticed as missing from device when retrieved by removing with the trocar it was in the abdomen through.When retracting the ligasure it got partially stuck.It was finally removed by direct visualization.All pieces were accounted for and nothing broke off completely.Nothing was left behind.This was a reprocessed piece of equipment from covidien.

• Brand Name: REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDERS
• Type of Device: ELECTROSURGICAL, CUTTING & COAG, LAP & ENDOSCOPIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• MDR Report Key: 8678827
• MDR Text Key: 147361153
• Report Number: 8678827
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/23/2019,05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: LF1637
• Device Lot Number: 9902552
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/23/2019
• Date Report to Manufacturer: 06/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14235 DA