MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS STRYKER REPROCESSED JAW SEALERS - SEALER, LIGASURE, MARYLAND, JAW, NANO; ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R

Model Number LF1937

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

During lap appy, dr started using ligasure and asked for replacement as this one had incomplete seal.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: STRYKER REPROCESSED JAW SEALERS - SEALER, LIGASURE, MARYLAND, JAW, NANO
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS
• MDR Report Key: 19005381
• MDR Text Key: 339058243
• Report Number: MW5153374
• Device Sequence Number: 1
• Product Code: NUJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: LF1937
• Device Lot Number: 15023505
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Sex: Male