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

Model Number	3973
Medical Device Problem Codes	Misfire (2532); Failure to Form Staple (2579); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	07/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a veterinary procedure, while being applied on anastomosis on an open jejunostomy, there was a poor staple formation where staples did not form complete b shape and noticed an incomplete staple line.It was also noted that staples fell into lumen.They performed colic surgery as surgical intervention and the surgical time was extended for 25 minutes.Later, they converted to hand sew to complete the case.The patient experienced colic post-operatively and eventually led to cardiac troponin.The patient is deceased.

• Brand Name: ILA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 8126518
• Report Number: 2647580-2018-05896
• Device Sequence Number: 1770846
• Product Code: GDW
• UDI-Device Identifier: 10884521063181
• UDI-Public: 10884521063181
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K885222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/03/2018

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: 3973
• Device Catalogue Number: 3973
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Weight: 453