MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN TA; STAPLE, IMPLANTABLE

Model Number	TA9048L
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	Death (1802)
Date of Event	08/18/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Analysis summary: post market vigilance (pmv) received the device.The visual inspection of the returned product noted the sulu had been fired.The pushers did not appear to be fully advanced.The middle pusher was only slightly advanced and no staples were present in the reload.Forwarded to engineering for evaluation of the middle pusher not advancing with the top and bottom pushers.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: occurred during an open thoracotomy procedure.Forty percent of the staplers were fired.The stapler partially fired.In order to resolve the issue and complete the case, used another reload.The patient expired during the case.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one stapling single use loading unit (sulu).Visual inspection of the device noted the sulu was fully fired.The staple pushers did not appear to be evenly deployed.Engineering reloaded the loading unit with staples and fired it on the appropriate test media.Proper staple formation was observed.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all medtronic quality release specifications at the time of manufacture.Our investigation was unable to determine a root cause or establish a relationship between the device and the reported incident.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): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• MDR Report Key: 6900767
• Report Number: 1219930-2017-07498
• Device Sequence Number: 13573759
• Product Code: GDW
• UDI-Device Identifier: 20884521043265
• UDI-Public: 20884521043265
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2017

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: 06/30/2021
• Device Model Number: TA9048L
• Device Catalogue Number: TA9048L
• Device Lot Number: P6F0620X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Initial Date Received by Manufacturer: 09/08/2017
• Supplement Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 09/28/2017
• Supplement Report FDA Received Date: 11/20/2017
• 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: Death