MAUDE Adverse Event Report: US SURGICAL PUERTO RICO GIA PREMIUM; APPARATUS, SUTURING, STOMACH AND INTESTINAL

Model Number	030424L
Medical Device Problem Codes	Component Missing (2306); Mechanics Altered (2984)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/02/2018
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, intra-operatively, the staples did not deploy for the reload was empty, it was without staples.The surgeon used another reload for the end of the procedure.No patient injury.
Additional Manufacturer Narrative
Additional information: evaluation summary post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted the reload displayed a full complement of staples.Damage was noted to the firing knob side of the knife blade channel.Microscopic inspection revealed no damage to the knife blade.Functional testing was precluded due to the observed condition of the device.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all medtronic quality release specifications at the time of manufacture.Replication of this condition may occur if an excessive force is applied to the knife blade assembly prior to firing.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: GIA PREMIUM
• Common Device Name: APPARATUS, SUTURING, STOMACH AND INTESTINAL
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 7280732
• Report Number: 2647580-2018-00830
• Device Sequence Number: 1237099
• Product Code: FHM
• UDI-Device Identifier: 20884523007098
• UDI-Public: 20884523007098
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K801590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 030424L
• Device Catalogue Number: 030424L
• Device Lot Number: P6L0622X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 02/19/2018
• Supplement Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1