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

Model Number	5DCS
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Upon visual inspection, the returned 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 5dcs was dull and would not cut correctly.There was no patient injury, medical intervention, and extended procedure time reported to retrieve another 5dcs was minimal.These are commonly used devices that are readily available.

• Brand Name: NA
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• MDR Report Key: 6075996
• Report Number: 0001056128-2016-00140
• Device Sequence Number: 16333047
• Product Code: NUJ
• UDI-Device Identifier: 00885825013288
• UDI-Public: (01)00885825013288(17)190125(10)4323259
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K110189
• 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): 10/07/2016

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: 01/25/2019
• Device Model Number: 5DCS
• Device Catalogue Number: 5DCSRR
• Device Lot Number: 4323259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2016
• Initial Report FDA Received Date: 11/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1