MAUDE Adverse Event Report: US SURGICAL PUERTO RICO PREMIUM PLUS CEEA; STAPLE, IMPLANTABLE

Model Number	111987
Medical Device Problem Codes	Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	06/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during laparoscopic rectal cancer resection, while doing end-to-end anastomosis of the two stumps, when device was fired, cutting operation was performed but no staples came out.A new end-to-end stapler was reopened in time and more normal tissues of the patient were cut for anastomosis.Surgical time was extended by thirty minutes or more due to the product problem.
Additional Manufacturer Narrative
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.
Event or Problem Description
According to the reporter, during laparoscopic rectal cancer resection, while doing end-to-end anastomosis of the two stumps, when device was fired, cutting operation was performed but no staples came out.The device was taken out of the patient and medical staff tried to fire the stapler again - there were indeed no staples.A new end-to-end stapler was reopened in time and more normal tissues of the patient were cut for re-anastomosis.Surgical time was extended more than thirty minutes due to the product problem.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted one fully applied device.The green indicator was visible within the window upon receipt and safety was engaged.The pusher fingers were intact and did not appear to be damaged.No damage to the knife blade staple guide was observed.The staple guide was attached to the instrument.The anvil was received tilted and separated from the instrument.There was a shallow impression on the anvil cutting ring.The anvil had markings in the divots that showed staples being fired on the anvil.Functionally, the wing nut and safety functioned properly.The green indicator was visible within the window when the wing nut was fully closed.The instrument was applied to test media.Pusher-fingers and knife advance when handles were squeezed.The knife cut the test media cleanly and completely.The device produced all audible, tactile and visual indicators.No functional abnormalities were observed.It was reported that the staples did not deploy from the stapler after the handle was squeezed and or time was extended by more than 30 minutes resulting from product failure.The reported issues could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: the cut ring was partially severed or intact.The product analysis noted evidence that the device was not used as intended.The issue can occur if the instrument handle compression was not completed or if the instrument was applied against an excessive amount of tissue during the clinical application.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: 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 or incomplete knife cut.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): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: justin ellis ; 5920 longbow drive; 8200 coral sea st ne; mounds view,mn, CO 55112 ; 7635265677
• MDR Report Key: 15036587
• Report Number: 2647580-2022-02419
• Device Sequence Number: 6943963
• Product Code: GDW
• UDI-Device Identifier: 10884523006605
• UDI-Public: 10884523006605
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K001895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2022

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: 02/28/2026
• Device Model Number: 111987
• Device Catalogue Number: 111987
• Device Lot Number: P1C1513S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 07/12/2022; 09/08/2022
• Initial Report FDA Received Date: 07/16/2022
• Supplement Report FDA Received Date: 07/27/2022; 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Weight: 75 KG