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

Model Number	015451L
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Codes	Tissue Damage (2104); No Code Available (3191)
Date of Event	03/20/2018
Type of Reportable Event	Serious Injury
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 an anterior resection of the rectum procedure, while closing of the stump, there were 3 loads did not create a correct line of staples on the intestine due to a leak in the intestinal stump.There were 4 attempts to close the stump so another load from another packaging was used and sewn manually to resolve the issue.A creation of a permanent colostomy was needed to prevent permanent impairment of a function.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of four devices disposable loading units opened by the account and devices disposable loading units sealed.The first three loading units were received fully fired.Microscopic inspection of the loading units anvil buckets revealed strike marks, suggesting the loading units had been fired.The fourth loading unit was received with a full complement of staples.No visual abnormalities were observed.The clinical instrument was not received.Three loading units were received sealed.No abnormalities were observed.Functionally, the first three loading units were reset, reloaded with staples.All the loading units were loaded into a post market vigilance (pmv) representative instrument.All the loading units were applied to test media with proper staple formations.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Should new information become available, the file will be re-opened, and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during an anterior resection of the rectum procedure, while closing of the stump, there were 3 loads did not create a correct line of staples on the intestine due to a leak in the intestinal stump.There were 4 attempts to close the stump so another load from another packaging was used and sewn manually to resolve the issue.A creation of a permanent colostomy was needed to prevent permanent impairment of a function.There was an extended hospitalization due to an event.The patient's status is fine.

• Brand Name: TA PREMIUM
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 7403299
• Report Number: 2647580-2018-01727
• Device Sequence Number: 1768376
• Product Code: GDW
• UDI-Device Identifier: 20884521047386
• UDI-Public: 20884521047386
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K855047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2018

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: 10/31/2022
• Device Model Number: 015451L
• Device Catalogue Number: 015451L
• Device Lot Number: P7K1005X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Initial Date Received by Manufacturer: 03/21/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 05/16/2018
• 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
• Patient Age: 64 YR
• Patient Weight: 100