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

Model Number	OMS-TTSS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during an open hernia repair, the device broke internally.The surgeon then used another device to resolve the issue in order to complete the case.There was no patient injury.

• 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: 11700268
• Report Number: 2647580-2021-01417
• Device Sequence Number: 3659328
• Product Code: GDW
• UDI-Device Identifier: 10884521070509
• UDI-Public: 10884521070509
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090470
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/21/2021

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: 05/31/2022
• Device Model Number: OMS-TTSS
• Device Catalogue Number: OMS-TTSS
• Device Lot Number: P7E0406X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR