MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD CLEARIFY; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 21-345

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 09/29/2023

Event Type  Injury  

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 a robotic sigmoid colectomy, upon use of the device for a final look before closure, it was noticed that the distal tip of the device had been severed off.After the surgeon took a long look around and the patient was closed.The surgeon then decided to have an x-ray where an object was detected near the abdominal wall.So, a second diagnostic laparoscopy was performed and new trocars introduced into abdomen where a review of the previously closed trocar sites showed the piece of device stuck between the peritoneum and fascia of the anterior abdominal wall.It was removed and patient closed without further incident.The surgical time was extended for more than 2 hours due to the issue.

Event Description

According to the reporter, during a robotic sigmoid colectomy, upon use of the device for a final look before closure, it was noticed that the distal tip of the device had been severed off.After the surgeon the surgeon took a long look around and the patient was closed.The surgeon then decided to have an x-ray where an object was detected near the abdominal wall.So, a second diagnostic laparoscopy was performed and new trocars introduced into abdomen where a review of the previously closed trocar sites showed the piece of device stuck between the peritoneum and fascia of the anterior abdominal wall.It was removed and patient closed without further incident.The surgical time was extended by more than 2 hours due to the issue.

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 a trocar wipe tip had disengaged.Functionally, the tactile inspection of the power switch confirmed that the switch was fully activated.The device was dismantled, and new batteries were connected to the device.The device was activated, led turned on and device was warming.The device batteries were drained.It was reported that a component disengaged from the device into the surgical cavity.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur when excessive force is applied during clinical application.It was also reported that operating room time was extended by more than 30 minutes resulting from product failure.The reported issue could not be confirmed.The most likely cause could not be established from the information available.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: trocar wipe and microfiber cloth are radiopaque.Grasp the blue handle and push the foam head straight into the trocar.Do not release or bend the trocar wipe.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: CLEARIFY
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 18017000
• MDR Text Key: 326676831
• Report Number: 9612501-2023-01857
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521213562
• UDI-Public: 10884521213562
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

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: 21-345
• Device Catalogue Number: 21-345
• Device Lot Number: D3E2078Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2023
• Supplement Dates Manufacturer Received: 10/31/2023
• Supplement Dates FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2023
• 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): Required Intervention; Other
• Patient Age: 62 YR
• Patient Sex: Male