MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGIDAC; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number 173024

Device Problems Break (1069); Detachment of Device or Device Component (2907); Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body In Patient (2687); Unintended Radiation Exposure (4565)

Event Date 09/06/2023

Event Type  Injury  

Manufacturer Narrative

D10 concomitant product: 173016, 173016 endo stitch instrument (lot#j2l1953ey).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 a laparoscopic hernia repair (thoracic) procedure, while being used on the tissue, the device was difficult to toggle and the needle broke in half.Half of the needle remained on the handle and the other half has yet to be identified. x-ray was then brought into the room to locate the needle.This led to 30 minutes or more extended surgical time.A new handle and reload were used to complete the procedure.

Manufacturer Narrative

Additional information: b5, g3, h6 (additional fdp (c34620) and ime (e2008) codes) 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 a laparoscopic hernia repair (thoracic) procedure, while being used on the tissue, the device was difficult to toggle and the needle broke in half.Half of the needle remained on the handle and the other half fell into the patient's cavity.X-ray was then brought into the room to locate the needle.The surgeon determined it would cause more harm to open the patient to search for the needle. therefore, half of the needle remained in the patient.This led to 30 minutes or more extended surgical time.A new handle and reload were used to complete the procedure.The patient did not have an extended recovery period and is home.

Manufacturer Narrative

Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the needle was broken at the attachment site.A suture was returned unattached to the needle.Less than one inch of suture was attached to needle.Damage to the needle was noted on the opposite side of the loading slot.It was reported that the device was difficult to toggle and the needle broke in half.Half of the needle remained on the handle and the other half fell into the patient's cavity.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.These issues may occur when the needle was not loaded properly or when the needle was forced into an obstacle.This condition may also occur if excess pressure is exerted on the needle or the attached suture while the jaws are in the open position.In these situations, the needle may flex and ultimately break.The evaluation detected an unreported condition: of improperly loaded needle.The product analysis noted evidence that the device was not used as intended.This issue may occur if either the endo stitch dlu has incorrect orientation or the endo stitch suturing device is held with the printed information facing down when the needle is loaded in the device.In some instances, the needle becomes lodged in between the jaw and the slot of the blade making it impossible to unload.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: ensure that the toggle levers are fully retracted prior to opening the jaws of the device.The reloading button should never be pressed when the instrument is in the body cavity, as this will release the needle.Inspect the application site to ensure hemostasis.Place additional sutures or use electrocautery if necessary to complete hemostasis.Endoscopic procedures should be performed only by physicians having adequate training and familiarity with endoscopic techniques.A thorough understanding of the operating principles, risks versus benefits, and the hazards involved in utilizing an endoscopic approach is necessary to avoid possible injury to the user and/or patient.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: SURGIDAC
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 17812382
• MDR Text Key: 324186649
• Report Number: 9612501-2023-01623
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10884521129450
• UDI-Public: 10884521129450
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2024

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
• Device Operator: Health Professional
• Device Model Number: 173024
• Device Catalogue Number: 173024
• Device Lot Number: J9H0127Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2023
• Initial Date FDA Received: 09/25/2023
• Supplement Dates Manufacturer Received: 09/18/2023; 01/29/2024
• Supplement Dates FDA Received: 10/10/2023; 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2019
• 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
• Treatment: PLEASE SEE NOTE ON H10
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female