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

Model Number	3971
Medical Device Problem Codes	Material Separation (1562); Misfire (2532); Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2020
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 distal gastrectomy, the cartridge was attached to the stapler, and when an attempt was made to fire the device on the stomach, the shaft pushing out the knife and the staples broke, and the device could not be used.As far as the sample was seen, most of the staples have been fired.The procedure was completed with another device.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection noted the single use loading unit (sulu) was fully applied.The knife assembly and white sleeve were disengaged.Additionally, the knife blade assembly was bent.The pusher thumb piece was intact.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.Replication of the reported condition occurs when the firing handle is over retracted prior to firing.Replication of the damaged knife blade assembly condition may occur if excessive force is applied to advance the firing knob during application over a thick tissue.The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a distal gastrectomy, the cartridge was attached to the stapler, and when an attempt was made to fire the device on the stomach, the staples came out by firing, the knife was not pushed out.The device could not be used.As far as the sample was seen, most of the staples have been fired.The procedure was completed with another device.The surgical time was extended by less than thirty minutes.There was no patient injury.

• 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: 9864198
• Report Number: 2647580-2020-01019
• Device Sequence Number: 13584790
• Product Code: GDW
• UDI-Device Identifier: 10884521063167
• UDI-Public: 10884521063167
• 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,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2020

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: 05/31/2024
• Device Model Number: 3971
• Device Catalogue Number: 3971
• Device Lot Number: P9F1265Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1