MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. N/A; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES, REPROCESSED

Model Number LF1837

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/26/2021

Event Type  malfunction  

Event Description

Stryker reprocessed ligasure blunt tip without nano-coating 37cm laparoscopic sealer/divider faulty during surgery.Doctor aware and another device was opened and used.

• Brand Name: N/A
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 5300 region court; lakeland FL 33815
• MDR Report Key: 12158508
• MDR Text Key: 261273677
• Report Number: 12158508
• 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: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF1837
• Device Catalogue Number: LF1837
• Device Lot Number: 12605411
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13505 DA