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

Model Number	B11LT
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Upon visual inspection of the returned device, there was evidence of clinical use.Visual inspection of the cannula housing and sleeve revealed no damage.The broken piece returned with the complaint device was part of the obturator tip wing.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.Devices are rejected for any obturator tip damage.The device was unlikely to have been released from stryker with the reported failure mode.The most likely root cause is contact with a hard object or other improper handling during the procedure.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.Do not use excessive force.The bladeless trocar should not be advanced for additional penetration once complete entry has been made into the operative cavity.Possible injury to the internal structures could result due to continued entry of the obturator.The obturator is designed with the optical feature to minimize the risk of penetrating injury to intra-abdominal and intra-thoracic structures.Observe standard precautionary measures for all obturator insertions.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported when the surgeon went to sew the fascia, a piece of the trocar was discovered.The piece was retrieved and matched up to the trocar tip to ensure all pieces were recovered before stitching up the patient.There was no patient injury, medical intervention, and extended procedure time reported was minimal.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: 6089385
• Report Number: 0001056128-2016-00147
• Device Sequence Number: 10933157
• Product Code: NLM
• UDI-Device Identifier: 00885825014278
• UDI-Public: (01)00885825014278(17)190614(10)4657294
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 10/14/2016

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: 06/14/2019
• Device Model Number: B11LT
• Device Catalogue Number: B11LTRR
• Device Lot Number: 4657294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2016
• Initial Report FDA Received Date: 11/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1