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

Model Number	017612
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Tissue Damage (2104); Injury (2348); No Code Available (3191)
Date of Event	07/19/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter: occurred post operatively following a total colectomy with latero-latero ileo-rectal anastomosis.The device was used to close the rectum.No issues were apparent during the procedure, but eight days post-operatively the patient was admitted to the er.The surgeon discovered an anastomotic leak.Temporary injury was caused; the renal failure was normalized and respiratory failure is improving.To correct the issue, the anastomosis was excised and a terminal ileostomy placed.The surgeon reported he will attempt to reconstruct the transit and reverse the ileostomy.There will be an additional operation to correct the issue.The patient was in intensive care at the time of the report.Patient status is alive, with injury.Patient has now been discharged from the icu.The ileostomy had not been reversed as the surgical team would evaluate if it is possible to do it before the patient is discharged.Patient relevant medical history: diabetes, aneurysm of descending thoracic aorta.

• Brand Name: ROTICULATOR
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 6811400
• Report Number: 2647580-2017-06179
• Device Sequence Number: 11196593
• Product Code: GDW
• UDI-Device Identifier: 10884521047693
• UDI-Public: 10884521047693
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K855047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/24/2017

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 Expiration Date: 09/30/2020
• Device Model Number: 017612
• Device Catalogue Number: 017612
• Device Lot Number: P5J0079X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 08/22/2017
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 69 YR