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

Model Number	3971
Medical Device Problem Codes	Failure to Form Staple (2579); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event was previously submitted on a summary report.Subsequently, medtronic has received additional information which is being submitted via this 3500a.Post market vigilance (pmv) led an evaluation of one device.Visual inspection noted the device was partially fired to the 1 cm mark with some stapler pushers not fully deployed.The knife blade assembly was observed to be damaged.Functional testing was precluded due to the observed damage.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.Replication of this condition may occur if excessive force is applied to advance the firing knob during application over a thick tissue.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.
Event or Problem Description
According to the reporter: for the second firing of the functional end-to-end anastomosis in laparoscopic right hemi-colectomy, the surgeon started the firing at the closure of insertion ,however the plastic knob became stiff before reaching at the staple line of functional end-to-end anastomosis.The surgeon continued the firing and sapling, however the knife was stopped on the halfway.Replaced by a new cartridge, the additional tissue resection with a new staple line was completed with no problem.The status of the patient is alive with no problem.
Additional Manufacturer Narrative
Initial notification of this reportable event to fda.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ILA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 7311023
• Report Number: 2647580-2018-01151
• Device Sequence Number: 1355153
• Product Code: GDW
• UDI-Device Identifier: 20884521063164
• UDI-Public: 20884521063164
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K885222
• 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
• Report Date (Section B): 03/06/2018

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: 11/30/2021
• Device Model Number: 3971
• Device Catalogue Number: 3971
• Device Lot Number: P6L0408X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Initial Date Received by Manufacturer: 07/29/2017
• Supplement Date Received by Manufacturer: 07/29/2017
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1