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

Model Number	5DCS
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been returned to stryker sustainability solutions for evaluation.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.A supplemental mdr will be submitted once the device evaluation is completed.The reported event will continue to be monitored through post-market surveillance.(b)(4).
Event or Problem Description
It was reported the surgeon was unable to cut with the laparoscopic scissors.The device was replaced, leading to a few minutes delay.There was no patient injury or medical intervention reported.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
The complaint device was returned to stryker sustainability solutions after the initial mdr was filed.Visual inspection revealed signs of clinical use.Debris was present on the blades.Inspection of the blades revealed wear.Upon functional inspection, the device was unable to provide a clean cut to due to the wear present on the blades.The most likely root causes are: user attempts to cut staples, clips, or non-soft tissue.Wear to blades due to clinical use.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported the surgeon was unable to cut with the laparoscopic scissors.The device was replaced, leading to a few minutes delay.There was no patient injury or medical intervention 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: 6380615
• Report Number: 0001056128-2017-00044
• Device Sequence Number: 13590822
• Product Code: NUJ
• UDI-Device Identifier: 00885825013288
• UDI-Public: (01)00885825013288(17)191102(10)5220059
• 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,Followup
• Report Date (Section B): 08/17/2017

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: 11/02/2019
• Device Model Number: 5DCS
• Device Catalogue Number: 5DCSRR
• Device Lot Number: 5220059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Initial Date Received by Manufacturer: 02/06/2017
• Supplement Date Received by Manufacturer: 08/04/2017
• Initial Report FDA Received Date: 03/06/2017
• Supplement Report FDA Received Date: 08/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1