MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R

Model Number LF1737

Device Problem Use of Device Problem (1670)

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

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to stryker sustainability solutions for evaluation.The device was discarded by the facility.As the device was not returned for evaluation, inspection was unable to be performed.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.The reported event may be attributed to: device not cleaned while in use per ifu guidance.Ancillary equipment failure.Trigger button (activation button) not engaged throughout the entire seal cycle.Device activated in contact with pooling fluid.Device used on vessels thicker than 7 mm.Grasping on too much tissue or inappropriate tissue types or on staples.Issue build-up, eschar prevents complete jaw opening the instructions for use (ifu) state: do not overfill the jaws of the instrument with tissue, as this may reduce device performance.Open the jaws by pushing forward on the lever to release tissue.Keep the instrument jaws clean.Build-up of eschar may reduce the seal and/or cutting effectiveness.Wipe jaw surfaces and edges with a wet gauze pad as needed.The reported event will continue to be monitored through post-market surveillance.Should the device become available for return, the investigation will be reopened.

Event Description

It was reported that the ligasure device kept giving an error code on the generator stating there was not enough tissue in the jaws.The jaws were opened and closed multiple times without resolution.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.

• Brand Name: NA
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• Manufacturer (Section G): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• Manufacturer Contact: marissa richmond ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 10673903
• MDR Text Key: 228700049
• Report Number: 0001056128-2020-00074
• Device Sequence Number: 1
• Product Code: NUJ
• UDI-Device Identifier: 07613327375817
• UDI-Public: 07613327375817
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2023
• Device Model Number: LF1737
• Device Catalogue Number: LF1737RR
• Device Lot Number: 11473566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 20 YR