MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD ENDO CLIP III; APPLIER, SURGICAL, CLIP

Model Number 176630B

Device Problems Entrapment of Device (1212); Mechanical Problem (1384); Mechanics Altered (2984)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 09/07/2022

Event Type  Injury  

Event Description

According to the reporter, during laparoscopic cholecystectomy, at cystic duct resection, the handle was squeezed but clip did not load properly and was malformed.The clip's main body could not be removed.To resolve the issue, additional trocar was placed.Using another clip applier, clipping was performed at both sides of the clip which had been unable to be removed and removed the device.

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 laparoscopic cholecystectomy, at cystic duct resection, the handle was squeezed but clip did not load properly and was malformed.The jaws locked on tissue and could not be removed.To resolve the issue, additional trocar was placed.Using another clip applier, clipping was performed at both sides of the clip which had been unable to be removed and removed the device.

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

Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted damage to the instrument consistent with application over an obstruction.The wishbone link was disconnected from the trigger handle and the trigger was flaccid.Functionally, the three clips caught between the jaws were removed.The trocar was removed.The instrument was unable to be cycled as the handle was not connected to the internal linkage.The wishbone link was reattached.The instrument was reassembled, and seven clips were applied to test media with proper clip formation.When the cartridge was empty, the interlock engaged to prevent the jaws from approximating.It was reported that the clips did not load properly into the jaws as expected and did not close completely and were malformed.Also, the jaws of the device remain closed on tissue.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if the handle is forcefully pulled open prior to fully completing the full handle compression.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: prior to placing a clip, confirm that the jaws are positioned free of other clips or obstructions.Placing the jaws or firing the instrument over another clip or other obstruction may result in bleeding and or lack of hemostasis and or damage to the instrument jaws.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 III
• Type of Device: APPLIER, SURGICAL, CLIP
• 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: 15470844
• MDR Text Key: 300449519
• Report Number: 9612501-2022-01626
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10884521047266
• UDI-Public: 10884521047266
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071406
• 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,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 176630B
• Device Catalogue Number: 176630B
• Device Lot Number: J1G0098Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• 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