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

Model Number MCS20

Device Problems Mechanics Altered (2984); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: unknown.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.Attempts are being 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.

Event Description

It was reported that during and unknown procedure, the mcs20 clip applier has cut through a big vessel.It did not work right.It is unknown how the procedure was completed.Patient consequence was not reported.

Manufacturer Narrative

(b)(4).Date sent: 12/9/2020.D4: batch # u93m8f.H2: additional information received: sales rep reports catalog number could be msm20 (and that is what analysis site also received).Investigation summary : the analysis results found that the msm20 device was returned with no apparent damage and with a clip in the jaws.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 six clips as intended.The event described could not be confirmed as the device performed without any difficulties noted.Although there is no direct evidence of use error, the instructions for use do contain the following: "caution: ensure that each clip is securely and completely placed around the tissue being ligated." it should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.H11=corrected data= d4 d4: catalog is msm20.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10839968
• MDR Text Key: 216410678
• Report Number: 3005075853-2020-06004
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002499
• UDI-Public: 10705036002499
• 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: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCS20
• Device Catalogue Number: MSM20
• Device Lot Number: U40D4H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Date Manufacturer Received: 11/16/2020
• Patient Sequence Number: 1