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

Model Number	GIA10048L
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2019
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, during a distal gastrectomy procedure, the device partially fired.A new device was used to resolve the issue and complete the procedure.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The single use loading unit (sulu) was received partially applied and the interlock was engaged.No damage was noted to the knife blade.The sulu was reset and loaded the sulu into a pmv 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 reported condition may occur if the firing stroke is not complete and the firing knob is not fully retracted after firing or if the instrument is applied against an excessive amount of tissue during the clinical application.If the firing knob is not fully retracted, difficulty in unloading the loading unit may be experienced, and may prevent further loading from occurring.The instructions for use (ifu) states that to remove the sulu, separate the instrument halves.Holding the cartridge-half of the instrument, grasp the proximal end of the sulu tabs and pull up and out to remove the sulu from the instrument.To place a new sulu into the instrument, hold the sulu by the proximal end tabs and insert into the cartridge fork at a 30 to 45 degree angle from the distal end down until the unit snaps into place.Remove shipping wedge after sulu is fully loaded.Sulu will ¿float¿ up and down in final loaded position.The root cause of the observed damage was due to the product not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• Brand Name: GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 8853610
• Report Number: 2647580-2019-03973
• Device Sequence Number: 259913
• Product Code: GDW
• UDI-Device Identifier: 20884521031705
• UDI-Public: 20884521031705
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2019

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: 07/31/2023
• Device Model Number: GIA10048L
• Device Catalogue Number: GIA10048L
• Device Lot Number: P8G1458X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1