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

Model Number	TA3048L
Medical Device Problem Codes	Entrapment of Device (1212); Misfire (2532); Failure to Form Staple (2579)
Health Effect - Clinical Codes	Tissue Damage (2104); No Code Available (3191)
Date of Event	05/16/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter: occurred during an open bronchial throat and pericardium cuff procedure.The stapler partially fired.The staple line was incomplete.To fix the staple line, over sewed, resected and re-stapled.There was tissue damage as a result of the problem.Clip seam not completely closed and there clips remain hanging in the magazine, new forklift used.The damage was not considered permanent.The patient needed a pericardium cuff.After the pericardium cuff and the occlusion of the bronchial throat, there was no further injury.The surgical time was extended by thirty minutes or more due to the product problem.The patient status is alive, with injury.
Additional Manufacturer Narrative
Post market vigilance (pmv) received two device.The visual inspection of the returned product noted that the reloads were fully fired.There was no observed damage to the reloads.Pmv performed functional testing which included resetting and reloading the sulus with staples.The sulus were then loaded into device and test fired.The jaws closed smoothly, the pin slide advanced fully, and the handle actuated smoothly into pre-clamped and clamped position.The jaw opened, handles unlocked and pin slides retracted when the black release buttons were depressed.The instruments and sulus were fired over test media with acceptable staple formation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: per additional information received.The stapler was used for the first time at the end of the procedure to cut off the bronchus stump.It caused an unnecessary loss of pericardium.Another clamping was necessary because of the incomplete row of clamps.The damage was not considered permanent.The patient needed a pericardium cuff.The current patient status is ok.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.There were no visual or functional abnormalities observed during the product analysis.The sulus were reloaded with staple and fired on the test media with proper staple formation.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.

• 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: 6637801
• Report Number: 2647580-2017-05575
• Device Sequence Number: 91910
• Product Code: GDW
• UDI-Device Identifier: 10884521043121
• UDI-Public: 10884521043121
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K111825
• 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,Followup,Followup
• Report Date (Section B): 08/01/2017

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: 03/01/2019
• Device Model Number: TA3048L
• Device Catalogue Number: TA3048L
• Device Lot Number: P4C0749X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Initial Date Received by Manufacturer: 05/16/2017
• Supplement Date Received by Manufacturer: 06/26/2017; 08/01/2017
• Initial Report FDA Received Date: 06/13/2017
• Supplement Report FDA Received Date: 07/21/2017; 08/29/2017
• 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: Other; Required Intervention