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

Model Number LF1937

Device Problem Material Deformation (2976)

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

Event Date 02/26/2024

Event Type  malfunction  

Event Description

It was reported the device arrived visibly broken at the jaws.There was no reported patient injury or medical intervention and the extended procedure time reported was four minutes.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, there was no evidence of bio-burden present on the device.The handle, blade trigger, button, shaft, and jaws appeared to be intact with the exception of the jaw having some damage.The visual inspection of the complaint device revealed the bottom jaw was bent near the tip.The light grey plastic mold was separated from the jaw being held by thin metal that the spacer pad are attached too.A small piece of chipboard was stuck between the metal jaw and the plastic cover.The jaw functionality was tested and confirmed to be acceptable as the jaw lever was able to actuate the jaws multiple times.The jaw lever was returned to the start position and the jaws open when released.An audible click was heard when the jaw lever engaged the click tab and a second click was heard when engaging the purple activation button.Despite having jaw damage the jaws were in the locked position.The blade trigger was tested and verified to maintain proper movement.The results of the visual inspection determined that the reported event was confirmed.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: device damage to mechanisms during use; overmold separation; shipping damage, manufacturing damage.Dropped in pre-op inspection.Attempting to remove the device from the trocar with the jaws in the open position.The instructions for use (ifu) state: in minimally invasive surgery, inspect the outer surfaces of the instrument before insertion through the cannula to ensure that there are no rough or sharp edges that could damage tissue.Remove instrument from tray by firmly pulling on the handle.Do not pull on the instrument jaws or cable.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.Notice ¿ do not turn the rotation wheel when the lever is latched.Product damage may occur.Notice ¿ do not engage the cutting mechanism over clips, staples, or other metal objects as damage to the cutter may occur.Do not attempt to clean the instrument jaws by activating the instrument on wet gauze.Product damage may occur.Do not clean the instrument jaws with a scratch pad or other abrasives.The reported event will continue to be monitored through post-market surveillance.

• Brand Name: NA
• Type of Device: 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: 18991597
• MDR Text Key: 338990159
• Report Number: 0001056128-2024-00033
• Device Sequence Number: 1
• Product Code: NUJ
• UDI-Device Identifier: 07613327504897
• UDI-Public: 07613327504897
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180499
• 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
• Report Date: 03/27/2024

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
• Device Operator: Health Professional
• Device Model Number: LF1937
• Device Catalogue Number: LF1937RR
• Device Lot Number: 15309163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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