MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. LIGASURE; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES, LAPAROSCOPIC ENDOSCOPIC

Catalog Number LF1637

Device Problems Mechanical Problem (1384); Device Displays Incorrect Message (2591)

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

Event Date 08/22/2018

Event Type  malfunction  

Event Description

A ligasure blunt tip laparoscopic sealer/divider 5mm x 37cm was opened to the field and connected to the ligasure unit.Dr.Attempted to use the unit when an error code came up reading as follows, "seal not complete, please attempt to seal device again." dr.Attempted to reseal device and it did not work.Unit was disconnected and reconnected and still did not seal properly.A new device was opened and worked well.

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES, LAPAROSCOPIC ENDOSCOPIC
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 w. drake dr.; tempe AZ 85283
• MDR Report Key: 7929978
• MDR Text Key: 122668844
• Report Number: 7929978
• 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: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LF1637
• Device Lot Number: 8603165
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/05/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2018
• Type of Device Usage: N
• Patient Sequence Number: 1