MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC GIA 50 PREMIUM* 3.8 STAINLESS STEEL DLU; STAPLE, IMPLANTABLE

Model Number	030424L
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
According to the reporter: the magazine made a cut, but did not deploy any staples.The operator noticed afterwards that there are no staples inside the magazine.The "pusher," the yellow bar that runs under the staples inside the reload to push them out for deployment, also appeared to be missing.A new magazine was used.It was reported that reinforcement material was not employed.Additional information was requested from the account but has not yet been received.
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of two gia premium¿ auto suture¿ loading unit 50mm - 3.8mm stainless steel dlus opened by the account.The initial visual inspection of the instrument noted that sulu labeled 1 was received fully fired and sulu labeled 2 was received with a full complement of staples.The knife blades are in the sheaths.The pusher thumb pieces were intact.Lubricant was noted in the knife blade assembly chamber of sulu 2.Functional testing was precluded for sulu 1 due to its fully fired condition.The gia 50 premium sulu 2 was loaded into a representative instrument.The firing knob and knife bar was fully functional.The sulu and representative device cut the test media cleanly and completely.The firing knob advanced smoothly during functional testing.Pressure distortions are observed in sulu 1 at the ends of the pushers which are consistent with force applied during staple formation.In addition indentations caused by the tips of formed staple legs are observed.Both sulus show lubricant residue at the distal end of the channel.This lubricant is applied at this area as part of the standard operating procedure for this device.A review of the device history record indicates this device lot number was released meeting all medtronic quality release specifications at the time of manufacture.The ifu states to dispose of the loading unit immediately after each use.Never reuse any disposable parts.The reported condition could be attributed to the user unintentional use of an already fired sulu.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce 00731
• MDR Report Key: 5527187
• Report Number: 2647580-2016-00123
• Device Sequence Number: 13577952
• Product Code: GDW
• UDI-Device Identifier: 20884523007098
• UDI-Public: 0120884523007098
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K801590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 030424L
• Device Catalogue Number: 030424L
• Device Lot Number: P5D0039X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2016
• Supplement Report FDA Received Date: 06/01/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention