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

Model Number 3948L

Device Problem Detachment Of Device Component (1104)

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

Event Date 06/15/2018

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 bypass of gastroenterostomy, the nurse tried to connect the reload to the handle, however the plastic knob came off the cartridge.They then replace a new cartridge to resolve the issue in order to complete the case.The product was not used for patient.There was no patient injury.

• 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 middleotwn ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7658453
• MDR Text Key: 113016666
• Report Number: 2647580-2018-03278
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 3948L
• Device Catalogue Number: 3948L
• Device Lot Number: P7A0086X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2018
• Date Device Manufactured: 01/05/2017
• 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