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

Model Number	LF1637
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation.As the device was not returned for evaluation, inspection was unable to be performed.A review of the dhr for the reported lot number supports that the device met all inspection and test criteria prior to release from stryker.The reported event could be attributed to: - grasping on to too much or inappropriate tissue or staples.- device damage to mechanisms during use.- removing the device from the trocar with the jaws in the open position.The instructions for use (ifu) state: - use the appropriately sized trocar to allow for easy insertion and extraction of the instrument.- carefully insert and withdraw the instrument through the cannula to avoid damage to the device and/or injury to the patient.- close jaws using device lever before insertion/extraction in the trocar.- do not turn the rotation wheel when the lever is latched.Product damage may occur.Turn the gray rotation wheel on the instrument until the jaws are in the required position.- do not attempt to clean the instrument jaws by activation the instrument on wet gauze.Product damage may occur.- do not clean the instrument jaws with a scratch pad or other abrasives.The reported event will continue to be monitored through post-market surveillance.Should the device become available for return, the investigation will be reopened.
Event or Problem Description
It was reported the ligasure broke near the proximal end of the jaw.This occurred when the surgeon used the device to dissect fascia within the body.He clamped the ligasure to some tissue and tried to separate the tissue by pulling down.It was when he pulled down it appeared that the "lockbox" part distal to the jaws broke apart.The pin was loose causing the flat metal piece to partially separate from the pin.Both pieces remained on the device within the patient and upon removal from the patient.An x-ray was shot to verify that nothing was retained in the patient from the device.There was a 4-8 minute delay.A new device was opened to successfully complete the procedure.There was no patient injury 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: 7184701
• Report Number: 0001056128-2018-00003
• Device Sequence Number: 135930
• Product Code: NUJ
• UDI-Device Identifier: 00885825017620
• UDI-Public: (01)00885825017620(17)201107(10)7484014
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K133578
• 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): 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/07/2020
• Device Model Number: LF1637
• Device Catalogue Number: LF1637RR
• Device Lot Number: 7484014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 01/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1