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

Model Number	GIA8038RL
Medical Device Problem Codes	Break (1069); Component or Accessory Incompatibility (2897)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2020
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, when the nurse was setting up the device for the first firing during a total pelvic exenteration procedure, the knife cover was found to be functional and the cartridge couldn't be combined with the stapler.It was also reported that, there was a crack in the key part of the knife cover.The procedure was completed without problems by using a new cartridge.The device was not used in the patient.There was no patient injury.
Additional Manufacturer Narrative
Additional information: d10, g4, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the loading unit displayed a full complement of staples and the interlock was engaged and damaged.Functionally, the instrument interlock was reset and the instrument was applied with no abnormalities.It was reported that the device broke and was difficult to load.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur due to improper loading of the cartridge.The manufacturing records for each device are also thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: the device should not be used on tissue such as liver or spleen where compressibility is such that closure of the instrument would be destructive.Tissue thickness should be carefully evaluated before firing any stapler.If the tissue cannot comfortably compress to the specified minimum requirement, or compresses to less than this requirement, the tissue may be too thick or thin for the selected staple size.Do not fire the device if serial numbers on anvil and cartridge halves do not match.Mismatched halves of the device may result in improperly formed staples, which may compromise the integrity of the wound closure and may result in leakage or disruption of the closure.When positioning the stapler on the application site, ensure that no obstructions, such as clips, are incorporated into the instrument jaws.Firing over an obstruction may result in incomplete cutting action and/or improperly formed staples.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: RELIAMAX
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 10254902
• Report Number: 1219930-2020-02734
• Device Sequence Number: 2679550
• 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,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2020

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 Model Number: GIA8038RL
• Device Catalogue Number: GIA8038RL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 67