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

Catalog Number MCM20

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Improper or Incorrect Procedure or Method (2017)

Patient Problems Hematoma (1884); No Code Available (3191)

Event Date 04/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Unknown, assumed 1st day of month that compliant was reported.Batch # unk.As a lot/batch was not provided, a device history could not be performed.

Event Description

It was reported that the doctor performed an ent free flap on a patient, where three clips were deployed on an unknown artery.The patient returned to the doctor on an unknown date with a hematoma.The doctor reoperated and found the clips had fallen off of the artery.It was not reported how the reoperation was completed or the status of the patient.

• 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: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7590680
• MDR Text Key: 110751594
• Report Number: 3005075853-2018-10529
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 20705036002472
• UDI-Public: 20705036002472
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MCM20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1