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

Model Number	OMS-TTSS
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2019
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 laparoscopic inguinal hernia repair, the device jammed half way through the tacking process.A new device was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
This event has been reassessed and found to be a non-mdr reportable complaint.If information is provided in the future, a supplemental report will be issued.

• 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: 9198497
• Report Number: 2647580-2019-05220
• Device Sequence Number: 448018
• Product Code: GDW
• UDI-Device Identifier: 10884521070509
• UDI-Public: 10884521070509
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 11/01/2019

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: 02/28/2023
• Device Model Number: OMS-TTSS
• Device Catalogue Number: OMS-TTSS
• Device Lot Number: P8B1257X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1