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

Model Number	030452
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2019
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 laparoscopic lung lobectomy, when the surgeon used the staple reload to cut the tissue, a yellow scrap was found that fell into the patient¿s cavity.The surgeon grasped the scrap to resolve the issue to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Post market vigilance (pmv) led a photographic evaluation of two photos.A visual inspection of the returned photos noted a loading unit shipping wedge and a yellow fragment were inside of a bag.The fragment is not seen inside of the patients cavity.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.A definitive root cause could not be determined with regard to the reported condition.Without the physical product, a definitive root cause could not be identified.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.
Additional Manufacturer Narrative
Additional information: d4(mfr name, street 1, mfr city, country code, postal code), evaluation summary: post market vigilance (pmv) led an evaluation of one shipping wedge of the loading unit.Visual inspection of the returned product noted that only shipping wedge of the loading unit was returned.Damage on shipping wedge tab was observed.In addition (pmv) performed a photographic evaluation of two photos and the visual inspection of the returned photos noted a loading unit shipping wedge and a yellow fragment were inside of a bag.The fragment is not seen inside of the patients cavity.Functional testing could not be performed since the device was not received.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 shipping wedge damage may occur if the shipping wedge pull tab is pulled in a lateral fashion towards the distal end of the single used loading unit (sulu) channel rather than away from the channel, or if the loading unit is clamped prior to removal of the yellow shipping wedge.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.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 06473
• MDR Report Key: 9399345
• Report Number: 1219930-2019-06654
• Device Sequence Number: 19521052
• Product Code: GDW
• UDI-Device Identifier: 10884523002836
• UDI-Public: 10884523002836
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Followup
• Report Date (Section B): 06/05/2020

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: 06/25/2023
• Device Model Number: 030452
• Device Catalogue Number: 030452
• Device Lot Number: T8E075X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 12/17/2019; 05/20/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 12/27/2019; 06/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1