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

Catalog Number MCM20

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Additional information was requested and the following was obtained: did the clip fire on the vessel? did the clip form completely? was the clip secure on the vessel, or did the clip fall off or move on the vessel? did the clip not fire at all? did the clip fall or eject from the jaws of the device? in the event it stated that there was patient consequence.Please explain the patient consequence? if the procedure was extended: how did the extension of the procedure effect the patient condition intra-op or post -op? response: the clip did not clip the vessel.It was stated that when the clip was fired on the vessel, the clip did not clamp the vessel and did not injure the vessel.The clip did not clamp.Patient consequences: the surgery time was extended due to replacing the clip applier.I¿m not sure if there was any consequences after the procedure was done.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.Can you please follow-up to see if there were any patient consequences? if yes, please explain.

Event Description

An mcm20 was used during a procedure which did not clip the blood vessel as expected.It was tried a few times before he continued to open a new clip applier.Extended theatre time while awaiting for product to work.

Manufacturer Narrative

(b)(4).Batch # p9487g.Device analysis: the analysis results found that the mcm20 was received with no damage in the external components.In addition, the tyvek was returned along with the instrument.In an attempt to replicate the reported incident; the device was cycled, resulting in 1 partially-formed clip due to an anti-backup failure.The remaining 6 clips were fed and formed as intended.Finally, the instrument locked out.In order to evaluate the condition of the device¿s internal components, the device was disassembled.Upon disassembling, the anti-backup lever was found worn out.It is possible this condition was caused by attempting to squeeze the device handle when it was not fully returned or by stopping the firing sequence and pulling the handle open.The reported complaint was confirmed.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.Additional information was requested, and the following was received: can you please follow-up to see if there were any patient consequences? if yes, please explain.There were no other consequences besides extended theatre time that was reported.So there was no other consequences for the patent.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7637689
• MDR Text Key: 112461039
• Report Number: 3005075853-2018-10930
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 20705036002472
• UDI-Public: 20705036002472
• 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
• Type of Report: Initial,Followup
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• 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: MCM20
• Device Lot Number: R4002H
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/26/2018
• Date Manufacturer Received: 06/26/2018
• Patient Sequence Number: 1