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

Model Number	OMS-TTSS
Medical Device Problem Codes	Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: occurred during an umbilical hernia repair with mesh procedure.The patient had mild periumbilical pain.Both tacking devices crunched and then did not work.The event outcome was hospitalization.No injuries or complications were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: occurred during an umbilical hernia repair with mesh procedure.The patient had mild periumbilical pain.Both tacking devices crunched and then did not work.In order to correct the issue the devices were replace.No injuries or complications were reported.

• 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: 7205481
• Report Number: 2647580-2018-00369
• Device Sequence Number: 13686321
• Product Code: GDW
• UDI-Device Identifier: 20884521070506
• UDI-Public: 20884521070506
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K090470
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2018

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: 03/31/2022
• Device Model Number: OMS-TTSS
• Device Catalogue Number: OMS-TTSS
• Device Lot Number: P7C0329X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 01/20/2018
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR