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

Catalog Number ER320

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2018

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.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.Did the clip drop or eject from the jaws of the device unformed? or, did the device fire the clips and the clips did not close?.

Event Description

Impossible to use the device: it delivers the clips opened.Another device was used.No patient consequence.

Manufacturer Narrative

Batch # p94k6j device analysis: the er320 device was returned for analysis and upon inspection the jaws were found to be in a yielded condition.In an attempt to replicate the reported incident the device was functionally evaluated.Upon firing of the device, the remaining 9 clips were ejected due to the condition of the jaws; finally the instrument locked out as intended.In order to evaluate the condition of the internal components of the device, it was disassembled.Upon disassembling, no anomalies were found.Possible causes for the found condition of the yielded jaws may be if the device is closed over an existing hard object or clip placing stress on the jaws causing them to distort or yield and not return to their original dimensions/position or excessive application of torque to the jaws when positioning the device on a vessel.The reported complaint was confirmed.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.It is known from the history of the device that the condition of the jaws may lead dropping/ejected clips.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: 7597122
• MDR Text Key: 111440649
• Report Number: 3005075853-2018-10596
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 20705036012587
• UDI-Public: 20705036012587
• Combination Product (y/n): N
• PMA/PMN Number: K864102
• 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: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• 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: ER320
• Device Lot Number: R40032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Date Manufacturer Received: 07/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1