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

Catalog Number MCS20

Device Problem Inadequate User Interface (2958)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.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.Did the jaws of the device cut the vessel? or, did the clip cut the vessel? was there a clip in the jaws of the device when fired? how was the vessel repaired? please clarify: the handling of the device was difficult? was the device difficult to fire? how was the procedure completed? was there any patient consequence? if yes, please explain.

Event Description

During the procedure, the device cut the vessels instead of clip it.The handling of the device was difficult.

• 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: 7980006
• MDR Text Key: 124986689
• Report Number: 3005075853-2018-13717
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002499
• UDI-Public: 10705036002499
• Combination Product (y/n): N
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/01/2018

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 Expiration Date: 04/30/2023
• Device Catalogue Number: MCS20
• Device Lot Number: R40G74
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2018
• Initial Date FDA Received: 10/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1