MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number	174317
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Visual inspection revealed the jaws of the device were found to be aligned and without damage.The jaws of the device were found to be disconnected from the inner shaft of the device.The device was disassembled for further inspection.Inspection of the inner shaft found that the shaft pin was missing, damage was present on the inner shaft where the pin should be.The jaws showed shaft wear and damage where they connect to the inner shaft.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: attempting to grasp excess amounts of tissue.Excessive force applied to the jaws of the device.Attempting to actuate the handle while the ratchet switch is in the "locked" position.The instructions for use (ifu) state: careful handling of instruments is necessary to avoid damage or breakage as a result of excessive force.Inspect the instrument for overall condition and physical integrity.Do not use the instrument if the insulation has been compromised or if any damage is noted.Return the instrument and packaging to stryker sustainability solutions if it is not in acceptable condition for surgery.Follow a suitable endoscopic surgery protocol.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported the device (laparoscopic instrument) did not hold tissue properly.The jaws did not close tight enough to grab tissue and it kept slipping off.The device was 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: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• MDR Report Key: 7381680
• Report Number: 0001056128-2018-00018
• Device Sequence Number: 1147615
• Product Code: NWV
• UDI-Device Identifier: 00885825012557
• UDI-Public: (01)00885825012557(17)200803(10)6845950
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 03/29/2018

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: 08/03/2020
• Device Model Number: 174317
• Device Catalogue Number: 174317RR
• Device Lot Number: 6845950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1