MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN RELIAMAX; STAPLE, IMPLANTABLE

Model Number	GIA8038RL
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter during a subtotal gastrectomy, at the 1st firing the handle was locked and was unable to fire.The cartridge was replaced with a new one and used, but the situation was not improved.Just in case the handle was replaced together, the next cartridge was used without problems.The surgical time was extended by less than 30 min.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.The first loading unit noted was received with a full complement of staples and the interlock was engaged with no knife blade damage.The first loading unit noted was received with a full complement of staples and the interlock was engaged with no knife blade damage.Damage was noted to the interlocks of both loading units.Functional testing was precluded due to the damage to the interlocks.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 observed condition may occur as a result of the engaged safety lock due to improper loading of the cartridge.The root cause of the observed damage was due to the product not being used as indicated 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: RELIAMAX
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 9182257
• Report Number: 1219930-2019-05690
• Device Sequence Number: 14363311
• Product Code: GDW
• UDI-Device Identifier: 20884521168630
• UDI-Public: 20884521168630
• 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): 01/15/2020

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: 01/31/2022
• Device Model Number: GIA8038RL
• Device Catalogue Number: GIA8038RL
• Device Lot Number: N9BO135Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1