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

Model Number	OMS-TTSS
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Mechanical Jam (2983)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/30/2018
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 a laparoscopic hernia, the device jammed in the middle of the procedure.The device component fell into the cavity of the patient and was not retrieved.They opened a new device to complete the case.

• 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: 8199152
• Report Number: 2647580-2018-06307
• Device Sequence Number: 10808938
• Product Code: GDW
• UDI-Device Identifier: 10884521070509
• UDI-Public: 10884521070509
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K090470
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2018

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 Model Number: OMS-TTSS
• Device Catalogue Number: OMS-TTSS
• Device Lot Number: P7H11825X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 12/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1