MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED

Model Number	2B5LT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Visual inspection of the returned device shows evidence of clinical use.The device was returned with the cannula housing block but no obturator housing or optiview shaft.The cannula shaft was broken.Approximately 3 inches of shaft were broken off and 1 inch remained attached to the housing.Further inspection of the cannula shaft revealed damage to the end near the tip.A review of the dhr could not be performed as the lot number was not reported.Devices are rejected for any cannula shaft damage.The most likely root causes are contact with a hard object, excessive force applied to the device, or shipping and/or handling damage subsequent to distribution from stryker.The instructions for use (ifu) state: - minimally invasive procedures should be performed only by persons having adequate training and familiarity with minimally invasive techniques.Consult medical literature relative to techniques, complications, and hazards prior to performance of any minimally invasive procedure.- do not use excessive force.- using sterile technique, remove the instrument from the package.To avoid damage, do not flip the instrument into the sterile field.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported the trocar broke in the abdomen of the patient.All pieces were removed from the patient in two minutes through the other trocar with a laparoscopic grasper.There was no patient injury or medical intervention reported.These are commonly used devices that are readily available.

• Brand Name: NA
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• MDR Report Key: 6766011
• Report Number: 0001056128-2017-00100
• Device Sequence Number: 1967293
• Product Code: NLM
• UDI-Device Identifier: 00885825017248
• UDI-Public: (01)00885825017248
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K132629
• 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): 08/03/2017

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 Model Number: 2B5LT
• Device Catalogue Number: 2B5LTRR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2017
• Initial Report FDA Received Date: 08/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1