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

Model Number	TA3048L
Medical Device Problem Codes	Failure to Form Staple (2579); Failure to Fire (2610)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	05/28/2021
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, on an open sigmoidectomy, while transecting the colon, the surgeon had loaded a green reload onto a blue handle for the first firing.Surgeon said the device misfired and did not staple.Another green reload was loaded but the staples were barely deployed.Only the tips of the staples were deployed.None of the staples were completely deployed.A different device and a suture was used instead.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the loading unit had been partially applied.Functional testing found the advanced staples in the first single use loading unit (sulu) were reused and reset inside the cartridge.The instrument and the sulu 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.It was reported that the staples did not form as expected, and the device did not fire.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur when the firing stroke is not completed during application.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: to fire the instrument, squeeze the handle a second time until it reaches a solid stop and it locks in the back position.If the ins trument handle is partially squeezed during firing then released, bleeding may occur as the instrument was not fully fired.The black release button may be used to open the instrument at any time during approximation.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• 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: 12037486
• Report Number: 2647580-2021-02111
• Device Sequence Number: 1403453
• Product Code: GDW
• UDI-Device Identifier: 10884521043121
• UDI-Public: 10884521043121
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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: 12/31/2025
• Device Model Number: TA3048L
• Device Catalogue Number: TA3048L
• Device Lot Number: P1A1483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Initial Date Received by Manufacturer: 05/28/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 07/21/2021
• 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