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

Catalog Number MSM20

Device Problem Failure to Form Staple (2579)

Patient Problem Blood Loss (2597)

Event Date 04/10/2018

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.As a lot/batch was not provided, a device history could not be performed.Additional information was requested and the following was obtained: what is meant by devices would partially deploy a clip? does this mean clip did not feed all the way into jaws of the device when loading? or did the device actually feed the clips into the jaws, but when the device was fired, the clip would not deploy completely from the device jaws? no other details available.Was the clip malformed but still in the jaws of the device (the clip was not fired out of jaws)? or was a clip fired out completely from the device but the clip was malformed? after it had fired.Device had cut through the vessel instead of ligating it.Another device was used to stop the bleeding.

Event Description

It was reported that during an unknown procedure device would intermittently partially deploy a clip which would result in a malformed clip.Procedure was completed with another device of the same product code.There were no patient consequences reported.

Manufacturer Narrative

(b)(4).Batch # r92d28.Device analysis: the analysis results found that the msm20 device was received empty.After the last clip is used, the instrument is designed to lock out, which prevents the handles from being squeezed; therefore the functional test was not performed due to the returned condition of the device.No conclusion could be reached as to what may have caused the reported incident.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.The reported complaint could not be confirmed.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7508180
• MDR Text Key: 108190511
• Report Number: 3005075853-2018-09814
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 20705036002502
• UDI-Public: 20705036002502
• 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
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: MSM20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Date Manufacturer Received: 05/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1