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

Model Number	111981
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Tissue Damage (2104); No Code Available (3191)
Date of Event	07/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during creation of anastomoses on robotic laparoscopic low anterior resection, the wing nut was stuck and did not complete the turn when opening and the anvil did not fully tilt.The tissue was cut poorly, and the device was unable to be opened and remove from tissue.The surgeon had to cut out the tissue and the device was removed.This resulted to tissue damaged and anastomosis had to be re-operated.The event led to extended surgical time of more than 30 minutes and extend patient hospitalization for more than one week.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the staple guide noted the instrument was fully applied.Instrument was damaged, wing nut, bushing, safety release lever and tissue indicator were broken/disassembled from instrument.The anvil was jammed and could not be removed easily due to the damaged components not allowing the instrument to open properly.The anvil of the instrument was observed to be tilted.A shallow knife impression was observed along the cutline impression in the mylar cover.Functionally, the condition of the instrument precludes an evaluation.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.Replication of the reported condition may occur if the instrument handle compression is not completed or if the instrument is applied against an excessive amount of tissue during the clinical application.Also, the instructions for use of this product states: when firing the stapler, make sure to fully squeeze the instrument handle until the metal underside of the handle contacts the stapler body to the fullest extent.Partial or incomplete handle squeezes may result in unacceptable staple formation and/or incomplete knife cut.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.If information is provided in the future, a supplemental report will be issued.
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.

• 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: 8839750
• Report Number: 3006451981-2019-00159
• Device Sequence Number: 19479800
• Product Code: GDW
• UDI-Device Identifier: 20884523006572
• UDI-Public: 20884523006572
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: K001895
• 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): 11/26/2019

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: 12/09/2023
• Device Model Number: 111981
• Device Catalogue Number: 111981
• Device Lot Number: S8MC003X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 10/02/2019; 11/11/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 10/18/2019; 11/26/2019
• 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: Hospitalization; Required Intervention