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

Model Number	TA4548L
Medical Device Problem Codes	Misfire (2532); Failure to Form Staple (2579)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	07/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Evaluation summary: post market vigilance (pmv) led an evaluation of one device.A fully fired 4.8mm single-use loading unit (sulu) was received.There were no visual or functional abnormalities noted during pmv testing.The loading unit was reloaded with staples, loaded into the instrument and applied to test media with acceptable results.The staple line was properly formed.A review of the device history record could not be performed because the lot number was not provided.However, records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during resection of bowel on a low anterior resection, the device partially fired and had a poor staple formation.Staple incomplete was also noted during insertion of the device for end to end anastomosis.Another stapler was used and same issue occurred.Additionally, the staple disengaged to patient's cavity and were left as is often done with loose staples.The surgeon had to manually oversew the staple line to correct the issue.Surgical time was extended more than 30 minutes.The patient was brought back for surgery the next day and is currently in intensive care.

• Brand Name: TA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 9212537
• Report Number: 2647580-2019-05264
• Device Sequence Number: 18908606
• Product Code: GDW
• UDI-Device Identifier: 10884521043183
• UDI-Public: 10884521043183
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111825
• 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
• Report Date (Section B): 10/20/2019

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: TA4548L
• Device Catalogue Number: TA4548L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 10/20/2019
• 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; Required Intervention