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

Model Number GIA8038L

Device Problems Failure to Advance (2524); Misfire (2532)

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

Event Date 07/09/2018

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 cystectomy/ileal conduit, the surgeon started firing the device; however preset cartridge did not advance on the halfway.Replaced by new cartridge, same event occurred.They replaced the handle and firing was successful.

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.Visual inspection of the instrument noted that the center bar had retracted in the retainer.The loading unit displayed a full complement of staples and the interlock was set.No damage was noted to the knife blade.The single used loading unit(sulu) was loaded into a test unit.The test instrument and sulu 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 center bar retraction condition may occur if the loading units are unloaded improperly.After firing, if the firing knob is not fully retracted, difficulty in removal of the loading unit may be experienced and the center bar may fall back into the firing knob retainer.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: 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: 7718569
• MDR Text Key: 115195261
• Report Number: 2647580-2018-03719
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884523007251
• UDI-Public: 10884523007251
• 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: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2018

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: 01/31/2023
• Device Model Number: GIA8038L
• Device Catalogue Number: GIA8038L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/10/2018
• Initial Date FDA Received: 07/25/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 09/24/2018
• Supplement Dates FDA Received: 10/02/2018; 10/17/2018
• 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