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

Catalog Number MCS20

Device Problems Fluid/Blood Leak (1250); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2018

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.

Event Description

It was reported that during a coronary artery bypass grafting procedure the device was not clamping the clips flat all of the way.Some blood was able to leak before clamping closed on subsequent firings with the same device.Another like device was also used to complete the procedure.There were no patient consequences reported.

Manufacturer Narrative

(b)(4).Batch #: p94l1z, p94j6z, p94l6h.Device analysis: the analysis results found that one mcs20 device was returned with no damage in the external components.In addition, a plastic bag with a partially formed clip inside.In an attempt to replicate the reported incident, the device was tested for functionality.Upon testing, the device was cycled and it fed and formed the remaining 6 clips as intended.No conclusion could be reached as to what may have caused the reported incident.The reported complaint was confirmed.The batch history record was reviewed and identified an unformed clip falls out of the jaws or is ejected prior to being applied issue related to the reported incident were found.When this occurs, our quality system documents the necessary actions to ensure final product quality.The final quality release criteria were met before this batch was released for distribution (p94l1z, (p94j6z).In addition, no protocols or ncr related to the complaint, were found during the manufacturing process.Manufactured date: 12/19/2017.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process (p94l6h).Manufactured date: 12/21/2017.

• 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: 7446307
• MDR Text Key: 106158535
• Report Number: 3005075853-2018-09225
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 20705036002496
• UDI-Public: 20705036002496
• 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,Followup
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: MCS20
• Device Lot Number: R4009P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2018
• 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