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

Model Number	OMS-TTSD
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Adhesion(s) (1695); Pain (1994); Injury (2348); Ascites (2596)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product: pco15 (lot#: pjf00663); pco12 (lot#: plb00388); 177995p (lot#: p1h0643); oms-ttsd (lot#: p1h0142; p1h0843; unknown).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an incisional hernia.It was reported that after the implant, the patient experienced adhesions, pain, wound dehiscence, ascites, mesh divided, tack loose in tissue, and mesh failure.Post-operative patient treatment included revision surgery, removal of mesh and many protacks, implantation of new mesh, and closure dehiscence.

• Brand Name: TACKER
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 9791321
• Report Number: 2647580-2020-00850
• Device Sequence Number: 2495804
• Product Code: GDW
• UDI-Device Identifier: 10884521070486
• UDI-Public: 10884521070486
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K090470
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: OMS-TTSD
• Device Catalogue Number: OMS-TTSD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 03/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention