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

Model Number	030424L
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer reference number: (b)(4).This event was originally reported on a quarterly summary report and is being resubmitted per fda request.Summary evaluation: post market vigilance (pmv) led an evaluation two device loading units and two photographs.The event report alleges the products were used in a surgical procedure.The loading units were received were fully fired with observed damage to the knife blade.The two photographs showed the staple line in the tissue.The staples were not properly formed.One staple was visually noted to have straight legs.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Replication of this condition may occur if the loading unit and knife blade was applied over an obstruction, which results in a damaged knife blade and improperly formed staples.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.No relationship between the device and the reported incident was confirmed.Based on the evidence available the reported condition was confirmed.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.
Event or Problem Description
According to the reporter: occurred during an open hemicolectomy procedure.The stapling device was being used to divide the colon.There was poor staple formation.There was medical or surgical intervention needed to prevent a permanent impairment of a function.Extra sutures were put on the anastomosis.There was no unanticipated tissue loss or damage due to the product problem.The patient status is alive, no injury.

• 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: 6813418
• Report Number: 2647580-2017-06210
• Device Sequence Number: 18866392
• Product Code: FHM
• UDI-Device Identifier: 20884523007098
• UDI-Public: 20884523007098
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K855047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2017

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: 07/31/2021
• Device Model Number: 030424L
• Device Catalogue Number: 030424L
• Device Lot Number: P6G0482X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2017
• Initial Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1