MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*MCA SMALL APPLIER; CLIP, IMPLANTABLE

Catalog Number MCS20

Device Problems Failure to Form Staple (2579); No Apparent Adverse Event (3189)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 8/28/2023.D4: batch # unk.Additional information was requested and the following was obtained: "how was the bleeding controlled? by other hemostatics methods.Bipolar energy and surgicel.How much blood was lost (ml)? unknow.Did the patient require a transfusion? no.Was there any patient consequence or change in the post-operative care of the patient as a result of the event? (extended hospital stay, readmission, re-operation, etc.) unknow but i think that no".An analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during a cardiovascular procedure, the clips were dislodged from the blood vessels without being able to stop the bleeding.This lengthened the time of surgery.

Manufacturer Narrative

(b)(4).Date sent: 10/5/2023.D4: batch # unk.Additional information was requested and the following was obtained: "the incidence has been in one patient, with no complications attributable to our devices.The operating room reported this information (14 units).The client did not return the devices to report, as they had been discarded by the usual and daily security mechanism of the centre." "we have been able to contact the person responsible, after his absence for personal reasons, and he tells us that the clinicians are satisfied with the product today.They had some incidents in the closures of the clips at some specific moments of the surgery but they were able to resolve them with other clips.They report 14 units that they had noted as small incidents and for security reasons they have escalated them to us.They don't know how to specify exactly but they insist that as of today they are calm with this device.They have been technically trained on how to correctly handle the device to avoid incomplete closure of the clips.".

Manufacturer Narrative

(b)(4).Date sent: 12/1/2023.Additional information was requested and the following was obtained: "1.How many procedures or patients: 1.2.How many devices failed in each procedure and how: all devices failed in the same procedure, a total of 14.The clip does not grab, it is released, so the closed vessels continues to bleed.After talking to them, everything points to a misuse of the surgeon.They have been given relevant explanations and training.".

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 17638586
• MDR Text Key: 322178780
• Report Number: 3005075853-2023-06171
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002499
• UDI-Public: 10705036002499
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2023

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 Catalogue Number: MCS20
• Device Lot Number: 386C46
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: 09/19/2023; 11/03/2023
• Supplement Dates FDA Received: 10/05/2023; 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1