MAUDE Adverse Event Report: US SURGICAL PUERTO RICO STAT TACK; STAPLE, IMPLANTABLE

Model Number	OMS-TTSS
Medical Device Problem Codes	Positioning Failure (1158); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted the unit had disrupted timing.The handle was actuated and the remaining tacks deployed but seated improperly in the test media.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the reported condition is caused by an instrument that has been exposed to excessive force while applying helixes to a surface.If a helix is fired over improper surfaces it can provoke the exertion of excessive force to the handle causing the unit to disrupt the timing and to a possible jam.Based on the evidence available the reported condition was confirmed.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.
Event or Problem Description
According to the reporter, a hair strand was found inside the stat tack sterile pack before device was handed to surgeon for use.Device with hair was put to the side and new one was opened with no issue.Additionally, the tacks were able to be fired but had not been used in the patient as the product was contaminated.There was no patient involvement in this event.

• Brand Name: STAT TACK
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 7109036
• Report Number: 2647580-2017-08696
• Device Sequence Number: 1211607
• Product Code: GDW
• UDI-Device Identifier: 20884521070506
• UDI-Public: 20884521070506
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K090470
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2017

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: 01/31/2022
• Device Model Number: OMS-TTSS
• Device Catalogue Number: OMS-TTSS
• Device Lot Number: P7A0118X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 12/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1