MAUDE Adverse Event Report: STRYKER-ENDOSCOPY LAKELAND 5300; ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC,

Model Number LF1837

Device Problem Use of Device Problem (1670)

Patient Problem Renal Impairment (4499)

Event Date 11/06/2023

Event Type  Injury  

Event Description

It was reported the patient experienced a drop in hgb resulting in acute kidney injury and an extended hospital stay of five days because the device did not seal the vessel properly and took several attempts to properly seal the vessel.There was no other patient injury reported.The complainant is not aware of any medical intervention, and reported an extended duration of five minutes.These are commonly used devices that are readily available.

Manufacturer Narrative

The device was returned to stryker sustainability solutions for evaluation.Additional information will be provided once the investigation has been completed.

Manufacturer Narrative

The device was returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device, spacer pads were inspected for damage and none was found.The handle functionality was tested after the jaws were soaked in enzymatic cleaner to remove the excess dried bioburden.Excess bioburden surrounded the jaws the handle and blade trigger would not function.The handle functionality was tested and confirmed to be acceptable as it lock/unlock and the jaw lever was able to actuate the jaws multiple times.Thumb button feedback was acceptable as it was able to depress the pressure pad on the membrane switch and exhibited a tactile click; and the pressure pad disengaged when released.While the jaws were in the locked position, they were inspected and found to be properly aligned.The blade trigger was tested and verified to maintain proper movement with small amount of resistance.Manual continuity tests were performed per dwi1678 and confirmed to be acceptable.The device was then connected to the force triad generator and was recognized; the default number of power bars were displayed.The plug was manually manipulated while plugged into the force triad generator.No issues observed.The instrument was energized while grasping the test medium until the force triad generator signaled an error and a "check instrument" was displayed on the screen.The device was unable to complete any cycles.The results of the functional testing determined that the reported event was confirmed.A review of the dhr for the reported lot/serial number supports that the device met all inspection and test criteria prior to release from stryker.The reported event could be attributed to: - ancillary equipment failure - power outage.- trigger button (activation button) not engaged throughout the entire seal cycle - electrical connections damaged - not using enough force to connect/disconnect.Using device beyond cable length range.- 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 or tissue build up (eschar).- device not cleaned while in use per ifu guidance.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.

Event Description

It was reported the patient experienced a drop in hgb resulting in acute kidney injury and an extended hospital stay of five days because the device did not seal the vessel properly and took several attempts to properly seal the vessel.There was no other patient injury reported.The complainant is not aware of any medical intervention, and reported an extended duration of five minutes.These are commonly used devices that are readily available.

• Brand Name: NA
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC,
• Manufacturer (Section D): STRYKER-ENDOSCOPY LAKELAND 5300; 5300 region ct; lakeland FL 33815
• Manufacturer (Section G): STRYKER-ENDOSCOPY LAKELAND 5300; 5300 region ct; lakeland FL 33815
• Manufacturer Contact: andy dobos ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 18276253
• MDR Text Key: 329850196
• Report Number: 0001056128-2023-00028
• Device Sequence Number: 1
• Product Code: NUJ
• UDI-Device Identifier: 07613327500844
• UDI-Public: 07613327500844
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172856
• 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,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF1837
• Device Catalogue Number: LF1837RR
• Device Lot Number: 14995808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 12/27/2023
• Supplement Dates FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2023
• 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 Outcome(s): Hospitalization