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

Model Number NB12STF

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Information (3190)

Event Date 03/04/2016

Event Type  Injury  

Manufacturer Narrative

The complaint device was returned to stryker sustainability solutions for evaluation.During visual inspection it was determined that the reported event was confirmed.A review of the dhr could not be performed as the lot number was not reported.The trocar components and specifically the seal are rejected for any defects, loose particles, or any seal components with tears during the manufacturing process.Therefore, the device was unlikely to have been released from stryker with the reported failure mode.Therefore, the most likely root cause is excessive force applied during the procedure.The instructions for use (ifu) states: "do not use excessive force." "special care should be taken during insertion of bladed instruments so as not to damage the cannula valve, and/or seal resulting in desufflation of the operative cavity." the reported event will continue to be monitored through post-market surveillance.

Event Description

It was reported that a piece broke off the top of the device during the procedure.An x-ray machine was used to look for the piece and therefore additional anesthesia was required.It was confirmed that the piece was not in the body.These are commonly used devices that are readily available.

• Brand Name: NA
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• Manufacturer (Section G): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• Manufacturer Contact: moira barton varty ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 5538032
• MDR Text Key: 41556225
• Report Number: 0001056128-2016-00034
• Device Sequence Number: 1
• Product Code: NLM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NB12STF
• Device Catalogue Number: NB12STFCO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 34