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

Model Number GIA10038S

Device Problem Detachment Of Device Component (1104)

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

Event Date 05/25/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, at the first firing of proximal pancreatic duodenectomy procedure, the surgeon fully fired the device with no problem, then fully returned the firing knob to the initial position, however the firing knob disengaged from the instrument.The nurse re-engaged the firing knob to the instrument, however they stopped using the device.The procedure was completed with new devices.There was no patient injury.

Manufacturer Narrative

Additional information: evaluation summary: post market vigilance (pmv) led an evaluation of one device.There were no visual or functional abnormalities observed during product analysis.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.If information is provided in the future, a supplemental report will be issued.

• Brand Name: GIA
• 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: 7597149
• MDR Text Key: 110933059
• Report Number: 2647580-2018-02871
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 30884521031672
• UDI-Public: 30884521031672
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111825
• 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
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: GIA10038S
• Device Catalogue Number: GIA10038S
• Device Lot Number: P8A0677KLX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2018
• 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