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

Model Number	030452
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2019
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 laparoscopic appendectomy, while on appendix, the two reloads was not able to close.Clips were used instead to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of two devices.Visual inspection of the first loading unit noted that the staple cartridge was pre-fired and engaged in interlock.The jaws of the loading unit were clamped.Functionally, the jaws of the first loading unit were manually opened and loaded into a pmv instrument.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.Visual inspection of the second loading unit noted that the staple cartridge had a full compliment of staples.Functional testing of the second loading unit confirmed there were no abnormalities that would have caused or contributed to the reported condition.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.Staple pre-fi re and inability to open the jaws after clamping may occur under the following conditions.1.The shipping wedge has been removed or is no longer fully seated in the metal channel prior to loading.2.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.3.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 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.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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 CT 06473
• MDR Report Key: 9120672
• Report Number: 1219930-2019-05383
• Device Sequence Number: 2597660
• Product Code: GDW
• UDI-Device Identifier: 20884523002833
• UDI-Public: 20884523002833
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 11/27/2019

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: 06/15/2023
• Device Model Number: 030452
• Device Catalogue Number: 030452
• Device Lot Number: T8E064X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1