MAUDE Adverse Event Report: STRYKER-ENDOSCOPY LAKELAND 5300 LIGASURE BLUNT TIP WITHOUT NANO-COATING 37CM LAPAROSCOPIC SEALER DIVIDER; ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R

Model Number	LF1837
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer was shipped a broken ligasure.Product arrived to customer with broken jaw inside packaging.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Upon visual inspection, there was no bioburden on the jaw of the device.Further inspection showed evidence of all 6 spacer pads intact without being worn down past the acceptable criteria.Visual inspection of the device jaws revealed that the bottom jaw mold was separated from the metal structure hanging on by the jaw cable.Further inspection of the device packaging tray showed evidence of impact where the device jaw is positioned indicating potential cause for the device jaw separation.The device plug, which is stryker branded, was inspected for corrosion, damage, and deformation on both sides and none were found.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.Therefore, the most likely root causes are: use error: dropped.Failure mode: device damage during transport/storage 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.In case the instrument is accidently dropped on the floor, turn off the generator and unplug the instrument prior to discarding.Inspect the instrument and cords for breaks, cracks, nicks, or other damage before use.Failure to observe this caution may result in injury or electrical shock to the patient or surgical team or cause damage to the instrument.If damaged, do not use.Do not turn the rotation wheel when the lever is latched.Product damage may occur.Turn the rotation wheel on the instrument until the jaws are in the required position.The reported event will continue to be monitored through post-market surveillance.

• Brand Name: LIGASURE BLUNT TIP WITHOUT NANO-COATING 37CM LAPAROSCOPIC SEALER DIVIDER
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R
• 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: 19448799
• Report Number: 0001056128-2024-00062
• Device Sequence Number: 11566502
• Product Code: NUJ
• UDI-Device Identifier: 07613327500844
• UDI-Public: 07613327500844
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K172856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/06/2026
• Device Model Number: LF1837
• Device Catalogue Number: LF1837RR
• Device Lot Number: 15238428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown