MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN-MFG RELIAMAX; STAPLE, IMPLANTABLE

Model Number	GIA6048RL
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during an esophagectomy/gastric tube procedure, for the first firing for construction of gastric tube, they connected the load unit to the instrument.The surgeon clamped the tissue of stomach and tried to push the firing knob, however it was locked and could not push it.The procedure was completed with another device.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The loading unit was received partially applied and engaged in interlock.There were staples protruding from proximal staple cartridge channel.Functional testing included resetting the loading unit and reloaded into the test unit.The instrument and sulu were applied to 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 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 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: RELIAMAX
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN NORTH HAVEN-MFG; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7088281
• Report Number: 1219930-2017-09505
• Device Sequence Number: 864675
• Product Code: GDW
• UDI-Device Identifier: 10884521168626
• UDI-Public: 10884521168626
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122781
• 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): 01/10/2018

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: 02/29/2020
• Device Model Number: GIA6048RL
• Device Catalogue Number: GIA6048RL
• Device Lot Number: N7B0759X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Initial Date Received by Manufacturer: 11/13/2017
• Supplement Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1