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

Model Number 176630B

Device Problems Device Slipped (1584); Detachment of Device or Device Component (2907); Fail-Safe Problem (2936); Insufficient Information (3190)

Patient Problems Tissue Damage (2104); No Consequences Or Impact To Patient (2199)

Event Date 09/02/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, on a laparoscopic right hemicolectomy, during ligation of the superior mesenteric vein, the handle was stiff and could not be squeezed.Another device was opened.Although the 1st firing to the central side was performed using the new device, the clip fell off immediately after the firing.Another clip was fired but also fell off.Bleeding off less than 200 cc from the superior mesenteric vein occurred.There was tissue damage.The closure of the blood vessel was performed by hand sewing.The fallen clips were retrieved.Another device was used to complete the case.

Manufacturer Narrative

Additional information: g4, h3, h6 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 clip did not hold tightly to the vessel and detached, a component disengaged from the device into the surgical cavity, and the safety interlock deployed prior to all staples or clips firing.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.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 ; DO 0101
• MDR Report Key: 10552115
• MDR Text Key: 207501257
• Report Number: 9612501-2020-01332
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10884521047266
• UDI-Public: 10884521047266
• Combination Product (y/n): N
• PMA/PMN Number: K071406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

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 Expiration Date: 01/31/2023
• Device Model Number: 176630B
• Device Catalogue Number: 176630B
• Device Lot Number: J0B2830Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 10/16/2020
• Supplement Dates FDA Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR