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

Catalog Number MCL20

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.Date of event is 2019.Event day and event month were not provided.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.

Event Description

It was reported that during an unknown procedure in the last week, the clip applier cut before it clamped and was not stopping the bleeding.Case completed with harmonic to seal the vessels.There were no patient consequences.No additional information was available.

• 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: 9210383
• MDR Text Key: 199123183
• Report Number: 3005075853-2019-22878
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002468
• UDI-Public: 10705036002468
• 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: 09/24/2019

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: MCL20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/24/2019
• Initial Date FDA Received: 10/18/2019
• 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