MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LIGASURE MARYLAND JAW OPEN/LAP SEALER/DIVIDER; ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R

Catalog Number LF1737

Device Problem Defective Device (2588)

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

Event Date 06/17/2020

Event Type  malfunction  

Event Description

Maryland ligasure not functioning at start of case.Ligasure removed from sterile field and replaced with new device.Fda safety report id# (b)(4).

• Brand Name: LIGASURE MARYLAND JAW OPEN/LAP SEALER/DIVIDER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS ; tempe AZ 85283
• MDR Report Key: 10239381
• MDR Text Key: 197994396
• Report Number: MW5095390
• Device Sequence Number: 1
• Product Code: NUJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/01/2020

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 Expiration Date: 01/14/2023
• Device Catalogue Number: LF1737
• Device Lot Number: 11454837
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1