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

Model Number 174301

Device Problem Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

The device was returned to stryker sustainability solutions for evaluation.Visual inspection of the device revealed signs of clinical use.Debris is present on the blades of the device.The device was inspected under magnification and the blades revealed wear.Functional inspection revealed the blades to be dull and unable to provide a clean cut.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(s) are: user attempts to cut staples, clips, or non-soft tissue; wear to blades due to clinical use.The instructions for use (ifu) state: do not directly apply current to staples or clips.Instruments were designed for cutting soft tissue.Attempting to cut staples or clips may damage the instrument.If cutting of staples or clips is attempted, damage to instrument may occur.The reported event will continue to be monitored through post-market surveillance.

Event Description

It was reported the laparoscopic scissors were dull.The device was replaced.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.

• Brand Name: NA
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• Manufacturer (Section G): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• Manufacturer Contact: marissa richmond ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 7044911
• MDR Text Key: 93233597
• Report Number: 0001056128-2017-00138
• Device Sequence Number: 1
• Product Code: NUJ
• UDI-Device Identifier: 00885825012564
• UDI-Public: (01)00885825012564(17)190721(10)4746828
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012700
• 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: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2019
• Device Model Number: 174301
• Device Catalogue Number: 174301RR
• Device Lot Number: 4746828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2016
• 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