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

Model Number LF1837

Device Problems Mechanical Problem (1384); Use of Device Problem (1670); Output Problem (3005)

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

Event Date 08/25/2021

Event Type  malfunction  

Event Description

4 different patients all undergoing laparoscopic-assisted vaginal hysterectomy all had no patient injuries.During these 4 patients' procedures the 5 ligasure blunt tip without nano-coating 37 cm laparoscopic sealer/dividers either stopped working, would not work or showed a message that read the device already used or maxed out.These procedures spanned a 3 week period and the or surgical team has concerns about the recent frequency of like-devices being unusable.Manufacturer response for electrosurgical, cutting coagulation accessories, laparoscopic endoscopic, reprocessed, n/a (per site reporter): the stryker sustainability solutions representative is in conversation with our hospital's director of supply chain operations and is planning to see if medtronic performed a software upgrade and will audit the ft10 generators.In addition the representative indicated he'd place a formal complaint with sss on the failed ligasure devices.

• Brand Name: N/A
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES, LAPAROSCOPIC ENDOSCOPIC
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 west drake drive; tempe AZ 85283
• MDR Report Key: 12562332
• MDR Text Key: 274279017
• Report Number: 12562332
• 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
• Type of Report: Initial
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• 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: 12977573
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/16/2021
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17155 DA
• Patient Weight: 63