MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LARGE JAW OPEN SEALER/DIVIDER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 11LF4418

Device Problems Display or Visual Feedback Problem (1184); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 10/05/2022

Event Type  malfunction  

Event Description

Large jaw open sealer/divider entered an error mode and ceased to function while in use.The generator was powered down and this appeared successful, but only for a short period of time.The device was replaced.Fda safety report id# (b)(4).

• Brand Name: LARGE JAW OPEN SEALER/DIVIDER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; tempe AZ 85283
• MDR Report Key: 15597425
• MDR Text Key: 301865797
• Report Number: MW5112610
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11LF4418
• Device Catalogue Number: 11LF4418
• Device Lot Number: 14164005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American