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

Model Number	5DCS
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/03/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation.It was stated the device could not be located at the facility.Since there was no device returned, inspection could not be performed.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.The reported event could be attributed to: - user attempts to cut staples or clips, - user attempts to cut non-soft tissue, - user attempts to cut excessive amount of tissue.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.(b)(4).
Event or Problem Description
It was reported the laparoscopic shears were not sharp.The shears were replaced 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, LAPAROSCOPIC & ENDOSCOPIC, R
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• MDR Report Key: 6393626
• Report Number: 0001056128-2017-00048
• Device Sequence Number: 36292
• Product Code: NUJ
• UDI-Device Identifier: 00885825013288
• UDI-Public: (01)00885825013288(17)180528(10)3709515
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/09/2017

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 Expiration Date: 05/28/2018
• Device Model Number: 5DCS
• Device Catalogue Number: 5DCSRR
• Device Lot Number: 3709515
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2017
• Initial Report FDA Received Date: 03/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1