MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R

Model Number LF1837

Device Problem Material Deformation (2976)

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

Event Date 01/10/2022

Event Type  malfunction  

Event Description

It was reported that upon opening the device on the field and prior to use, the device was identified as defective as a metal piece was protruding from the jaw.There was no patient injury or medical intervention and extended procedure time reported was 15 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, visual inspection revealed the jaws were bent.Further inspection revealed the bending of the jaws broke the jaw pin weld.Two holes in the plastic tray were observed that aligned with the jaws when the device is seated in the tray.No holes were observed in the chipboard box due to the device being returned in the wrong chipboard box.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 cause may be attributed to improper handling during transit or at the facility site.The instructions for use (ifu) state: inspect packaging before opening.The contents of the package are sterile if the package has not been compromised.Do not use the instrument if the sterility has been compromised.If the package is damaged or if it was opened and the instrument not used, return the instrument and the package to stryker.The contents of the package are provided sterile by method of ethylene oxide gas and is for single patient use only.Do not use if there is any evidence of damage to the package.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 SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• Manufacturer (Section G): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• Manufacturer Contact: andy dobos ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 13484323
• MDR Text Key: 289463853
• Report Number: 0001056128-2022-00005
• 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
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• 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: 13338672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2021
• 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 Age: 62 YR
• Patient Sex: Male