MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER; ELECTROSURGICAL, CUTTING & COAGULATION REPROCESSED

Model Number LF1637

Device Problems Loose or Intermittent Connection (1371); Defective Component (2292); Material Twisted/Bent (2981)

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

Event Date 10/08/2019

Event Type  malfunction  

Event Description

During laparoscopic surgery the jaws on the ligasure 1637 were noted to be twisting loose.The instrument was immediately removed from the port (patient) and examined.It was determined that the jaws were loose, but still intact.A new ligasure was provided to the field and the loose jaws were discarded from the field.The defective ligasure was placed back in the original packaging and sequestered.Surgery proceeded as planned.

• Brand Name: LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; 1810 west drake drive; tempe AZ 85283
• MDR Report Key: 9347647
• MDR Text Key: 167184119
• Report Number: 9347647
• 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: 11/08/2019

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: Health Professional
• Device Model Number: LF1637
• Device Catalogue Number: LF1637
• Device Lot Number: 9851793
• 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: 11/08/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 9490 DA