MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD ENDO CLIP; CLIP, IMPLANTABLE

Model Number 176625

Device Problem Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2022

Event Type  malfunction  

Event Description

According to the reporter, during a laparoscopic urologic surgery and kidney transplantation procedure, the surgeon felt that the ja ws' engagement (alignment) was poor.Clipping was still possible, thus the surgeon continued using the device.There was no patient 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.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device and photos were available for evaluation.Visual inspection noted the handle was broken and out position, in a manner consistent of cycling through the safety interlock.Functionally, it was observed that the jaws would not close upon actuation of the handle.The shaft was removed from the instrument body and the body was disassembled for visualization of internal components.The safety interlock channel lugs were broken.It was reported that the jaws were misaligned.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected unreported conditions: the handle was not in the correct position, and the safety interlock channel lugs were broken.Visual inspection of the returned photos noted the first photo depicts the instrument with the handle out of position, and the jaws open.The second photo depicts the body of the instrument with the handle out of position.The third photo depicts the top and the bottom of the jaws open.The fourth photo depicts the distal end of the jaws, appear to be co-plainer.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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: ENDO CLIP
• Type of Device: CLIP, IMPLANTABLE
• 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: 15241625
• MDR Text Key: 304457734
• Report Number: 9612501-2022-01406
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057845
• UDI-Public: 10884521057845
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: 176625
• Device Catalogue Number: 176625
• Device Lot Number: J9E3413NY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/03/2022
• Initial Date FDA Received: 08/17/2022
• Supplement Dates Manufacturer Received: 10/24/2022
• Supplement Dates FDA Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2019
• 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