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

Model Number	CB12LT
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Visual inspection showed the device was returned in two pieces with the cannula seal separated from the cannula base and shaft assembly.Two pieces of seal material were also included.Both seal pieces are part of the ring seal which has been separated from the ring seal assembly.All parts showed signs of clinical use.A review of the dhr supports that the device was unlikely to have been released from stryker with the reported failure mode.The most likely root cause is damage during insertion or withdrawal of instruments due to excessive force or other handling methods.The instructions for use (ifu) state: - become familiar with specific model of trocar and cannula prior to employing it in a surgical procedure to avoid damage to patient, to operator or to instrument.- careful handling of instruments is necessary to avoid damage or breakage.- inspect the instruments for any damage.Do not use the instrument if any damage is noted.Return the instrument and packaging to stryker sustainability solutions if it is not in acceptable condition for surgery.- care should be taken when introducing or removing instruments through the cannula sleeve in order to prevent accidental tearing of the seal.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported the washer fell off of the trocar during procedure.The washer did not fall into the patient.The piece was easily retrieved.The device was replaced with another trocar 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: LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• MDR Report Key: 6946503
• Report Number: 0001056128-2017-00126
• Device Sequence Number: 745278
• Product Code: NLM
• UDI-Device Identifier: 00885825014438
• UDI-Public: (01)00885825014438(17)200126(10)5748188
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K062497
• 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): 10/12/2017

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: 01/26/2020
• Device Model Number: CB12LT
• Device Catalogue Number: CB12LTRR
• Device Lot Number: 5748188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 10/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1