MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS STRYKER REPROCESSED LIGATURE DEVICE, 5MM, BLUNT TIP LAPAROSCOPIC LIGATURE; ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R

Model Number LF1837

Device Problem Arcing (2583)

Patient Problem Bowel Burn (1756)

Event Date 01/18/2021

Event Type  malfunction  

Event Description

Remote injury to small intestine after use of reprocessed ligature blunt tip lf 1837 by stryker sustainability solutions.Lot number with 12108892, 12230572, 12296549, or 12351537.This device was used for a laparoscopic appendectomy, and the patient had a remote small bowel injury suspected to be caused by arcing of current.This was a very easy to perform laparoscopic appendectomy.We could not identify any definite thermal injury on routine testing of the small bowel specimen.We have saved the specimen for further testing by fda if required.Original manufacturer is covidien.Fda safety report id # (b)(4).

• Brand Name: STRYKER REPROCESSED LIGATURE DEVICE, 5MM, BLUNT TIP LAPAROSCOPIC LIGATURE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; tempe AZ 85283
• MDR Report Key: 11307150
• MDR Text Key: 231570801
• Report Number: MW5099307
• Device Sequence Number: 1
• Product Code: NUJ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2021
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2023
• Device Model Number: LF1837
• Device Catalogue Number: LF1837
• Device Lot Number: 12108892
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24 YR
• Patient Weight: 70