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

Model Number	030452
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2019
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, on the first firing during a laparoscopic appendectomy, the firing did not advance and failed.The surgical time was extended by less than 30 minutes.The procedure was completed with another device.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the loading unit noted that the staple cartridge was pre-fired and engaged in interlock.There were staples protruding from proximal staple cartridge channel.The jaws of the loading unit were not clamped.Functionally, the loading unit was loaded into device that was sent with the loading unit.The jaws clamped and unclamped repeatedly without difficulty.The interlock was overridden and applied to test media.All staples were placed and test media was cleanly transected.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Staple pre-fire and/or inability to open the jaws after clamping may occur under the following conditions.The shipping wedge has been removed or is no longer fully seated in the metal channel prior to loading.The shipping wedge has been removed or is no longer fully seated in the metal channel and the jaws have been manually clamped prior to loading.The shipping wedge has been removed or is no longer fully seated in the metal channel and an attempt has been made to load a loading unit with the instrument firing rod extended.Please note that the yellow shipping wedge must be securely in place during instrument loading.The shipping wedge ensures that the single use loading unit (sulu) engages in the instrument to facilitate clamping and unclamping.Section #2 in the instructions for use, which accompanies each product shipment, cautions the user caution: do not attempt to remove the shipping wedge until the sulu is loaded into the instrument.The root cause of the observed damage was found to be due to the device 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: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• MDR Report Key: 8946510
• Report Number: 1219930-2019-04961
• Device Sequence Number: 11409277
• Product Code: GDW
• UDI-Device Identifier: 10884523002836
• UDI-Public: 10884523002836
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111825
• 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): 11/08/2019

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: 10/30/2023
• Device Model Number: 030452
• Device Catalogue Number: 030452
• Device Lot Number: T8K095X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1