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

Model Number LF1837

Device Problem Use of Device Problem (1670)

Patient Problem Perforation (2001)

Event Date 01/16/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned to stryker sustainability solutions for evaluation.The facility did not save the device for return as the procedure was initially thought to be completed successfully.As the device was not returned for evaluation, inspection was unable to be performed.A review of the dhr could not be performed as the lot number and/or serial number was not reported.The reported event could be attributed to: failure mode: damage to electrode path wiring and outer shaft shrink tube.Use error: activating device near conductive fluids without device clamped on tissue (potential to arc).The instructions for use (ifu) state: do not place the vessel and/or tissue in the jaw hinge.Place the vessel and/or tissue in the center of the jaws.Do not use this instrument on vessels larger than 7 mm in diameter.If the instrument shaft is visibly bent, discard and replace the instrument.A bent shaft may prevent the instrument from sealing or cutting properly.Eliminate tension on the tissue when sealing and cutting to ensure proper function.Use caution when grasping, manipulating, sealing, and dividing large tissue bundles.Do not attempt to seal or cut over clips or staples as incomplete seals will be formed.Contact between an active electrode and any metal objects may result in alternate site burns or incomplete seals.Do not activate the ligasure system in an open-circuit condition.Activate the system only when the instrument is in direct contact with the target tissue to lessen the possibility of unintended burns.A continuous tone sounds to indicate the activation of rf energy.When the activation cycle is complete, a two-pulsed seal-cycle-complete tone sounds and rf output ceases.Prior to cutting the seal, inspect the vessel or tissue to ensure proper sealing.Keep the instrument jaws (1) 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 physician performed an appendectomy with a ligasure device and the procedure was thought to be completed successfully with no patient injury, medical intervention or extended procedure time.However, the patient returned the next week with a hole in the small intestine 2 feet from the procedural location.An additional surgical procedure was required to treat the hole.These are commonly used devices that are readily available.

Manufacturer Narrative

Following submission of the initial mdr (0001056128-2021-00009), medwatch report mw5099307 was received.On 04/06/2021 through additional follow-up with the reporting facility it was determined that the medwatch report was for the same event for which the initial mdr was filed.The device was not returned to stryker sustainability solutions for evaluation.The facility did not save the device for return.The facility reported the patient underwent an uneventful laparoscopic appendectomy, so there was no delay and no injury was suspected.Therefore, the device was not saved by the facility.As the device was not returned for evaluation, inspection was unable to be performed.The facility reported multiple potential lot numbers for the complaint device (12108892, 12230572, 12296549, or 12351537).A review of the dhrs for all of the reported lot numbers supports that the device met all inspection and test criteria prior to release from stryker.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 physician performed an appendectomy with a ligasure device and the procedure was thought to be completed successfully with no patient injury, medical intervention or extended procedure time.However, the patient returned the next week with a hole in the small intestine 2 feet from the procedural location.This injury was reported to be a remote, full thickness, small bowel injury suspected by the facility to be caused by arcing or current.An additional surgical procedure was required to treat the hole.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
• MDR Report Key: 11355123
• MDR Text Key: 241425469
• Report Number: 0001056128-2021-00009
• Device Sequence Number: 1
• Product Code: NUJ
• UDI-Device Identifier: 07613327500844
• UDI-Public: 07613327500844
• Combination Product (y/n): N
• PMA/PMN Number: K172856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LF1837
• Device Catalogue Number: UNK_SUS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention