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

Model Number 3948L

Device Problems Failure to Advance (2524); Failure to Fire (2610)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a proximal pancreaticoduodenectomy, the surgeon clamped the tissue and started firing the device; however the knife did not advance.The procedure was completed with another device.There was no patient injury.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The loading unit was received fully fired with no damage to the knife blade.The knife blade and firing knob were advanced.The firing knob was retracted and the single-use loading unit (sulu) was reset and loaded into a pmv representative instrument.The sulu and representative device were applied to the appropriate test media with acceptable results.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 may occur if the firing stroke is not complete and the firing knob is not fully retracted after firing or if the instrument is applied against an excessive amount of tissue during the clinical application.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ILA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7694522
• MDR Text Key: 114551401
• Report Number: 2647580-2018-03535
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 20884521063157
• UDI-Public: 20884521063157
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K885047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 3948L
• Device Catalogue Number: 3948L
• Device Lot Number: P7F1189X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/17/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 10/05/2018
• Supplement Dates FDA Received: 10/02/2018; 10/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1