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

Model Number	176643
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Upon visual inspection, the complaint device showed signs of clinical use.The shaft and blades had debris present.Inspection of the blades revealed abnormal wear.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 or Problem Description
It was reported the endo shear scissors were not sharp enough to cut.The scissors were replaced with another device 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: 6089408
• Report Number: 0001056128-2016-00146
• Device Sequence Number: 18905577
• Product Code: NUJ
• UDI-Device Identifier: 00885825013264
• UDI-Public: (01)00885825013264(17)181204(10)4196686
• Combination Product (Y/N): N
• Initial Reporter State: PR
• 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): 10/18/2016

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 Expiration Date: 12/04/2018
• Device Model Number: 176643
• Device Catalogue Number: 176643RR
• Device Lot Number: 4196686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2016
• Initial Report FDA Received Date: 11/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1