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

Model Number	176643
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation.It was stated the device was discarded.As the device was not returned for evaluation, inspection was unable to be performed.No device information was reported as the device was not returned to stryker sustainability solutions.Therefore, the device history record (dhr) was unable to be verified.The reported event may be attributed to the user attempting to cut staples, clips, or non-soft tissue, resulting in a dull blade.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.Should the device become available for return, the investigation will be reopened.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported the laparoscopic scissors would not cut the suture, however the device was used to complete the procedure.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.

• Brand Name: NA
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• MDR Report Key: 6600061
• Report Number: 0001056128-2017-00077
• Device Sequence Number: 979778
• Product Code: NUJ
• UDI-Device Identifier: 00885825013264
• UDI-Public: (01)00885825013264
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K012700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/30/2017

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
• Operator of Device: Health Professional
• Device Model Number: 176643
• Device Catalogue Number: 176643RR
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2017
• Initial Report FDA Received Date: 05/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1