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

Model Number LF1837

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/14/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is currently in progress.The investigation results will be submitted in a supplemental mdr.

Event Description

It was reported x-ray was performed for a screw that came off the complaint device during a myomectomy.No further action was taken to resolve the missing screw and the extended procedure time reported was 20 minutes.These are commonly used devices that are readily available.

Manufacturer Narrative

Updates to: b1, d4, g3, g6, h2, h3, h4, h10, & h11.The device was returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device, it was revealed that one side of the jaw pin weld was broken, the other side was still intact.The jaw was carefully taken apart to verify the "screw" pin was connected to the jaw.The jaw functionality could not be tested due to the damaged jaw.The device inspection indicated that a portion of the reported event was confirmed.The visual inspection revealed that the jaw pin weld broke on one side of the jaw, however the jaw pin weld was intact on the other side and the jaws did not fully separate.The reported failure of ¿a screw came off in the patient¿ was not confirmed because visual inspection showed that the "screw" which is formally known as the jaw pin was still intact to the device.There are no other "screws" on the ligasure device that could have disassembled and fallen into the patient.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: -grasping on to too much or inappropriate tissue types or staples.-improperly forcing open the jaws of the device.-attempting to remove the device from the trocar with the jaws in the open position.The instructions for use (ifu) state: - use the appropriately sized trocar to allow for easy insertion and extraction of the instrument.- carefully insert and withdraw the instrument through the cannula to avoid damage to the device and/or injury to the patient.- close jaws using device lever before insertion/extraction in the trocar.- do not attempt to clean the instrument jaws by activation the instrument on wet gauze.Product damage may occur.- do not clean the instrument jaws with a scratch pad or other abrasives.- 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.- 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.

Event Description

It was reported x-ray was performed for a screw that came off the complaint device during a myomectomy.No further action was taken to resolve the missing screw and the extended procedure time reported was 20 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: 17733528
• MDR Text Key: 323247820
• Report Number: 0001056128-2023-00022
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• 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: 14891652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2023
• 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): Required Intervention