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

Model Number	EGIATRS45AMT
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Misfire (2532); Failure to Form Staple (2579)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2019
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 gastric band removal followed by gastroplasty, when the device was being used in the stomach, at the moment of the firing of both device, there was resistance in the structure of the stomach interrupting the firing therefore an incomplete firing.Both device have their staple line incomplete in the distal end.Another reload was used with the same handle to complete the case.There was no patient harm.
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of one device.Visual inspection of the returned product noted that the reload was partially fired with the interlock engaged.The jaws were open.Staple pushers were visible at the 3cm cut line.The sutures of both the anvil and the cartridge were released on the proximal end and remained intact on the distal end.Functionally the reload was loaded into a post market vigilance instrument, the interlock was over ridden, and the reload was applied to test media.All remaining 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.Replication of the partial fire condition with interlock engagement may occur when the firing handle has not been completely cycled.If the instrument return knobs are retracted at any point once the firing cycle has begun, the loading unit will engage into safety interlock and prevent further attempts to fire by ceasing the placement of staples and tissue transection, and prevent patient harm.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 act ions 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.
Event or Problem Description
According to the reporter during gastric band removal followed by gastroplasty, when the device was being used in the stomach, at the moment of the firing of both device, there was resistance in the structure of the stomach interrupting the firing therefore an incomplete firing.Both device have their staple line incomplete in the distal end.The staples were also not able to form a b-shape.Another reload was used with the same handle to complete the case.There was no patient harm.

• 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: 8829335
• Report Number: 1219930-2019-04446
• Device Sequence Number: 2654370
• Product Code: GDW
• UDI-Device Identifier: 20884521190884
• UDI-Public: 20884521190884
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K133938
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2020

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: 10/31/2019
• Device Model Number: EGIATRS45AMT
• Device Catalogue Number: EGIATRS45AMT
• Device Lot Number: N6K09085KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 01/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1