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	11/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.The returned complaint device showed signs of clinical use.The shaft and blades had debris present.Inspection of the blades revealed 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 causes are: user attempts to cut staples, clips, or non-soft tissue; wear to blades due to clinical use; user expectation of device functionality.The instructions for use (ifu) state: for some clamping instruments, the jaws can be clamped or locked onto tissue using the ratchet on/off switch on the handle.Manipulate the instrument so that the desired tissue is between the jaws or blades of the instruments and press the on position.Do not rotate the ratchet switch.Compress the handles until the jaws are in the desired position.The jaws can be closed or tightened further by compressing the handles again, but the jaws cannot be opened or loosened while the ratchet switch is in the on position; 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 that the laparoscopic scissors would not cut and the jaws were difficult to open.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: 6149901
• Report Number: 0001056128-2016-00159
• Device Sequence Number: 812871
• Product Code: NUJ
• UDI-Device Identifier: 00885825013288
• UDI-Public: (01)00885825013288(17)190728(10)4748445
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/09/2016

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: 07/28/2019
• Device Model Number: 5DCS
• Device Catalogue Number: 5DCSRR
• Device Lot Number: 4748445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2016
• Initial Report FDA Received Date: 12/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1