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

Model Number LF1837

Device Problem Break (1069)

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

Event Date 07/20/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is currently in progress.The investigation results will be submitted in a supplemental mdr.H3 other text : 81.

Event Description

It was reported the device tips disassembled during use during a laparoscopic bilateral salpingectomy.No piece fully detached - one side of the device's jaw detached from the rest of the piece, but was held in place with a metal rod.It was additionally reported by the customer that the patient did not suffer any negative effects mostly due to the diligence and skill of the surgeon involved.No medical intervention was reported and the extended procedure time was five minutes to remove the device from the patient's abdomen.The device was replaced to complete the procedure.These are commonly used devices that are readily available.

Event Description

It was reported the device tips disassembled during use during a laparoscopic bilateral salpingectomy.No piece fully detached - one side of the device's jaw detached from the rest of the piece, but was held in place with a metal rod.It was additionally reported by the customer that the patient did not suffer any negative effects mostly due to the diligence and skill of the surgeon involved.No medical intervention was reported and the extended procedure time was five minutes to remove the device from the patient's abdomen.The device was replaced to complete the procedure.These are commonly used devices that are readily available.

Manufacturer Narrative

The device was returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device reveals one of the jaw pads was separated from the jaw skeleton and hanging by the wire.Damage to the over-molded plastic was also observed.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: - 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: 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: 17627067
• MDR Text Key: 321994061
• Report Number: 0001056128-2023-00020
• Device Sequence Number: 1
• Product Code: NUJ
• UDI-Device Identifier: 07613327500844
• UDI-Public: 07613327500844
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF1837
• Device Catalogue Number: LF1837RR
• Device Lot Number: 14580431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2023
• 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