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

Model Number 176625

Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 07/01/2023

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.

Event Description

According to the reporter, during a laparoscopic cholecystectomy for symptomatic gallstone disease, the device caused a cut/rupture of cystic duct 3 consecutive times which led to further dissection of cystic duct proximally risking the integrity of common bile duct.At the end the aforementioned clip as used cautiously to clip distal cystic duct and after controlling the gallbladder side, cystic duct was transected via surgical shears and proximal cystic duct was closed using sutures very high up due to specified cuts putting side injury of common bile duct at stake.There was no visible injury at any of the surrounding organs, yet patient had to stay at hospital for at least 1 day more than it would usually require in order to confirm integrity of common bile duct biochemically the morning after procedure.It was also reported that the surgical time was extended by more than 30 minutes due to the device issue.

Manufacturer Narrative

H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the clips legs were malformed, crossed like a scissor.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.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: firing a clip over another clip or other obstructions may result in bleeding and/or leakage and may damage the instrument jaws.Also, avoid excessive twisting of the jaws or tissue manipulation when firing the instrument.Deflecting the jaws and/or shaft during firing may result in an improperly formed clip and possible bleeding and/or leakage.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: 17356785
• MDR Text Key: 319350680
• Report Number: 9612501-2023-01208
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057845
• UDI-Public: 10884521057845
• Combination Product (y/n): N
• Reporter Country Code: MT
• PMA/PMN Number: K143644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 176625
• Device Catalogue Number: 176625
• Device Lot Number: J1F1030NY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2021
• 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; Hospitalization
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 65 KG