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

Model Number	TA4548L
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	05/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, laparoscopic low anterior resection with loop ileostomy, while the device was being applied to the bowel, staples did not deploy.The tissue was cut thinking that the staples had deployed.The open tissue was managed and stapled stump with another manufacturer's product.It was also reported that the device did not fire using a second loading unit which unexpectedly open bowel lumen.New instrument was required and sutures were placed.The surgical time was extended by more than 30 minutes.There was no patient injury.
Additional Manufacturer Narrative
Additional information: evaluation summary: post market vigilance (pmv) led an evaluation of one photo and one device.The visual inspection of the returned photo depicts the single use loading unit(sulu) without the pushers advanced.No other visual abnormalities were observed.The visual inspection of the returned product noted the 4.8mm (sulu) was received with a full staple complement.The clinical instrument was received.Functionally; the sulu was loaded into the instrument and were applied to appropriate test media.The jaw closes smoothly, the pin slide advances fully, and the handle actuates smoothly into pre-clamped and clamped positions.The jaw opens, handle unlocks, and pin slide retracts when black release button is depressed.Acceptable staple formation was observed on test media.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.If information is provided in the future, a supplemental report will be issued.

• 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: 7587048
• Report Number: 2647580-2018-02804
• Device Sequence Number: 13504034
• Product Code: GDW
• UDI-Device Identifier: 10884521043183
• UDI-Public: 10884521043183
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2018

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 Expiration Date: 10/31/2022
• Device Model Number: TA4548L
• Device Catalogue Number: TA4548L
• Device Lot Number: P7K1059MX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 69