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

Catalog Number MCM20

Device Problems Failure to Form Staple (2579); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Event date: unknown, assumed 1st day of month that complaint was reported.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.(b)(4).

Manufacturer Narrative

(b)(4).Batch # p9423a.Device analysis: the analysis results found that the mcm20 device was returned 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 tested for functionality.Upon testing, the device was cycled and it fed and formed the remaining 12 clips as intended.As the device was found to be fully functional, it could not be determined what may have caused the reported incident.No conclusion could be reached as to what may have caused the reported incident.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.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7292927
• MDR Text Key: 101011497
• Report Number: 3005075853-2018-08165
• 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: User Facility
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: MCM20
• Device Lot Number: P4T674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Date Manufacturer Received: 03/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1