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

Catalog Number MCM30

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Only event day and year known: (b)(6) 2017.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.As a lot/batch was not provided, a device history could not be performed.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.When the "clip fell to - no support", did the device fire an unformed clip? if yes, what was the clip formation (scissored, malformed, clip gap, etc.)? if yes, did it fall off of the vessel it was applied to? or did the device drop or eject unformed clips? the batch and/or lot number you provided, plrr5r, is not a valid number.Do you have the correct batch and/or lot number for the device?.

Event Description

It was reported that when clipping the vessel, the clip fell to - no support.Successfully continued with another device.No patient consequences.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: when the "clip fell to - no support", did the device fire an unformed clip? if yes, what was the clip formation (scissored, malformed, clip gap, etc.)? if yes, did it fall off of the vessel it was applied to? or did the device drop or eject unformed clips? the batch and/or lot number you provided, plrr5r, is not a valid number.Do you have the correct batch and/or lot number for the device? no further information was obtained from the customer.Additional information received: the device will not return.

• 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: 7112968
• MDR Text Key: 95254853
• Report Number: 3005075853-2017-06710
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 20705036002489
• UDI-Public: 20705036002489
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MCM30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2018
• 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