MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS PREMIUM PLUS CEEA; STAPLE, IMPLANTABLE

Model Number	111981
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Form Staple (2579); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Tissue Damage (2104); No Code Available (3191); Unspecified Tissue Injury (4559)
Date of Event	10/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, while performing anastomosis between rectum and proximal sigma in a rectal cancer resection, some staples were not forming proper b shape.It was noted that it was difficulty removing stapler from cavity.Stapler was removed by rotating the stapler and with using force.As a result, was getting positive bubble test and after detailed inspection of anastomosis was visualized tissue tearing.A part of bowel with this anastomosis was removed and performed second anastomosis.Surgical time was extended by 30 minutes or more due device issue.
Additional Manufacturer Narrative
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: d8, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.A video was also provided.The evaluation found that there were staple formation issues and the wingnut was idle.It was reported that the staples did not form as expected, there was difficulty removing the device from the patient, and the leak test showed bubbles along the staple line.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: do not use the premium plus ceea¿ stapler on any tissue which cannot comfortably compress to 2 mm in thickness.The instrument should not be used if unusual effort is required to turn the wing nut in order to align the green approximation indicator with the grey tissue approximation bar.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.

• Brand Name: PREMIUM PLUS CEEA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• MDR Report Key: 10803648
• Report Number: 3006451981-2020-00175
• Device Sequence Number: 3931546
• Product Code: GDW
• UDI-Device Identifier: 10884523006575
• UDI-Public: 10884523006575
• Combination Product (Y/N): N
• Initial Reporter Country: UP
• PMA/510(K) Number: K001895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (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): 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2024
• Device Model Number: 111981
• Device Catalogue Number: 111981
• Device Lot Number: S9AC004X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 03/09/2021; 04/09/2021
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 03/31/2021; 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 73