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

Model Number	010911L
Medical Device Problem Codes	Failure to Form Staple (2579); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/12/2018
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 during a laparoscopic liver transplantation, after the stapling, the first cartridge was not separated properly, and the third cartridge was not removed at all at the same time there was poor staple formation as the staples didn't look like a "good b shape".A new device was used to complete the case.There was no patient harm.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the single use loading unit (sulu) was fully applied.Functionally, a cam bar was reset.The approximating lever opened fully and the sulus unloaded and loaded repeatedly without difficulty.The instrument and sulus were applied to test media with acceptable results; the pushers advanced and the staple line was properly formed.The sulus and instrument were subjected to a tissue capacity/clamp test with acceptable results.It was reported that the tip of a cartridge was broken.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if the cartridge of the single use loading unit (sulu) is subjected to excessive force when attempting to unload the device.The release button at the distal end of the instrument should be utilized for proper removal of the sulu.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: preoperative radiotherapy may result in changes to tissue.These changes may, for example, cause the tissue thickness to exceed the indicated range thickness for the staple size.Careful consideration should be given to any pre-surgical treatment the patient may have undergone and in corresponding selection of staple size.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MULTIFIRE ENDO TA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 8047024
• Report Number: 2647580-2018-05371
• Device Sequence Number: 19203679
• Product Code: GDW
• UDI-Device Identifier: 10884521047761
• UDI-Public: 10884521047761
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K910192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2020

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: 05/31/2023
• Device Model Number: 010911L
• Device Catalogue Number: 010911L
• Device Lot Number: P8E1206MX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Initial Date Received by Manufacturer: 10/13/2018
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1