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

Catalog Number MSM20

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Only event year known: 2018.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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.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 clarify if the complaint device is a competitor applier? you have provided the product code of msm20 with a lot number of p4t20v (an ethicon device), however, we would like you to confirm the correct product that was used.If it is the ethicon msm20 clip applier, can you please clarify whether or not the jaws of the clip applier caused the trauma to the vessel? or was a clip deployed onto the vessel and it caused the trauma to the vessel? if yes, what was the clip formation (unformed, malformed, clip gap, scissored, etc.)? how was the bleeding controlled? what was done to address the tear in the vessel? how was the procedure completed? was there any patient consequence? if yes, please provide further detail of the consequence.

Event Description

Whilst raising a pedicle flap for apr one competitor clipper caused a vessel to tear when applied.Caused trauma and bleeding to the vessel.

Manufacturer Narrative

(b)(4).Batch # p93l4t.The analysis results found that the msm20 device was returned with a clip in the jaws. 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 17 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 reported complaint could not be 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 obtained: this was definitely an ethicon clip applier used.Unfortunately i have no further information on the fault.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7681127
• MDR Text Key: 113934672
• Report Number: 3005075853-2018-11231
• 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,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: 07/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: MSM20
• Device Lot Number: P4T20V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Date Manufacturer Received: 07/25/2018
• Patient Sequence Number: 1