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

Catalog Number MCS20

Device Problem Unintended Ejection (1234)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.Additional information: it is unknown which lot number belongs to the device.Two lot numbers were provided: r4090p and r40d0p.The jaws were damaged and sharp.The jaws cut the artery.

Event Description

It was reported that during a coronary artery bypass graft with two vessel graft, the doctor was attempting to do a middle range clip.The mechanism that pushed the clip and crimps the clip, jumped out of the jaws and cut the lima graft that the surgeon was trying to attach to the heart.It was the left internal mammary artery.The doctor had to truncate the left internal mammary artery, to reconnect to the left anterior descending artery, due to the damage the clip had done to the left internal mammary artery.No patient consequences were reported.

Manufacturer Narrative

(b)(4).Date sent: 07/10/2018.Batch # r92n05.The analysis found that the mcs20 device was received with the floor damaged and with a clip in the jaws.In addition, the tyvek was returned along with the instrument.Due to this condition, no functional testing could be performed to evaluate the reported incident.6 clips were found inside clip track.A possible cause for the damages found is excessive force applied over the device.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The lot history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the packaging process.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

Manufacturer Narrative

(b)(4).Per photographic evaluation: a picture of the sample was received for analysis.Upon visual inspection of the picture, a mcs20 device can be observed, the device appears to be with no damage on the observed side on the photo.Refer to physical analysis for details on investigation on returned device.The photos do not provide enough evidence to determine root cause.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7597737
• MDR Text Key: 111437126
• Report Number: 3005075853-2018-10601
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: MCS20
• Device Lot Number: R4090P
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/12/2018
• Date Manufacturer Received: 07/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1