MAUDE Adverse Event Report: US SURGICAL PUERTO RICO PROTACK; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 174006

Device Problems Loss of or Failure to Bond (1068); Positioning Failure (1158); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Foreign Body In Patient (2687)

Event Date 04/13/2023

Event Type  malfunction  

Manufacturer Narrative

D10 concomitant product: 174006 protack 5mm disp in (lot#: p2f0413).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.

Event Description

According to the reporter, during the laparoscopic sacrocolpopexy, while using the mesh and tacker for prolapse, the tacks fell into the patient cavity.It was also mentioned that the tacker did not fire and no tacks deployed.The surgical time was extended for more than 30 minutes.It was stated that there was more bleeding and complications as a result of the event.A competitor's product was used to complete the procedure.

Event Description

According to the reporter, during the laparoscopic sacrocolpopexy, while using the mesh and tacker for prolapse, the tacks fell into the patient cavity.It was also mentioned that the tacker did not fire and no tacks deployed.The surgical time was extended for more than 30 minutes.It was stated that there was more bleeding and complications as a result of the event.All components were able to be retrieved using a grasper.A competitor's product was used to complete the procedure.

Manufacturer Narrative

H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the tacks were visible in the shaft and the timing was disengaged from the instrument.Functionally, trigger was jammed.It was actuated after disassembling the body from the tube.It was reported that a component disengaged from the device into the surgical cavity, the tack did not fixate properly into the tissue, and the device did not fire tacks as expected.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if there's an instrument that has been exposed to excessive force while applying helical fastener to a surface.If a helical fastener is fired over improper surfaces, it can provoke the exertion of excessive force to the handle causing the unit to disrupt the timing and to a possible jam.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 instrument on tissue which cannot be inspected visually for hemostasis.A minimum of 4mm tissue thickness is required when applying the helical fastener over underlying bone, vessels, or viscera.Applying excessive pressure against the nose of the instrument may stall and or jam the instrument.New information has been received pertaining to the event.This event has been reassessed and the reportability has been determined to be a malfunction reportable.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.

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 Description

According to the reporter, during the laparoscopic sacrocolpopexy, while using the mesh and tackers for prolapse, the tacks fell into the patient's cavity.It was also mentioned that the two tackers did not fire and no tacks were deployed.The surgical time was extended for more than 30 minutes.It was stated that there was more bleeding and complications as a result of the event.All components were able to be retrieved using a grasper.A competitor's product was used to complete the procedure.

Event Description

According to the reporter, during the laparoscopy procedure, while using the mesh and tackers for prolapse, the tacks fell into the patient cavity.It was also mentioned that the two tackers did not fire and no tacks were deployed.The surgical time was extended for more than 30 minutes.It was stated that there was more bleeding and complications as a result of the event.All components were able to be retrieved using a grasper.A competitor's product was used to complete the procedure.

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: PROTACK
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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 ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 16834954
• MDR Text Key: 314211302
• Report Number: 2647580-2023-01788
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521070400
• UDI-Public: 10884521070400
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K090470
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 174006
• Device Catalogue Number: 174006
• Device Lot Number: P2F0413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female