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

Model Number MCM30

Device Problems Mechanics Altered (2984); No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/18/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: please clarify how the device ¿would not properly close upon release.It side walled the vessel and misfired,¿.Did device not feed clips? did device feed clips sideways? did device not fire clips (jammed)? did device fire malformed clips? did device fire scissored clips? if other, please specify.What amount of blood loss (mls) occurred? was a transfusion required? was there any change to the procedure as a result of the event? were there any patient consequences? if yes, please describe.

Event Description

It was reported that during an unknown procedure the device pierced through the vein and would not properly close upon release.It side walled the vessel and misfired, causing bleeding and resulting in significant blood loss.They then used manual clips, gel foam, thrombin, and cause to address the bleeding.No further information is available.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; *
• MDR Report Key: 14356088
• MDR Text Key: 291391161
• Report Number: 3005075853-2022-03047
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002482
• UDI-Public: 10705036002482
• Combination Product (y/n): N
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCM30
• Device Catalogue Number: MCM30
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1