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

Model Number ER420

Device Problems Failure to Form Staple (2579); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # u9493u.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during an unknown procedure, the clip was not fed into the jaws properly during the second firing, and the deployed clip was not formed properly.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

Manufacturer Narrative

(b)(4).Date sent: 11/10/2020 d4: batch # u9493u investigation summary the analysis results found that the er420 device was returned with no apparent damage.The device was tested for functionality.During the analysis, the device was cycled, and it fed, retained, and formed the remaining one clip 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: do not excessively twist or torque the instrument jaws when positioning the instrument on a vessel and firing.Excessive twisting or torquing may result in clip malformation." 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 lot/batch number, and no non-conformances were identified.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10711475
• MDR Text Key: 212297050
• Report Number: 3005075853-2020-05434
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012597
• UDI-Public: 10705036012597
• 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: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ER420
• Device Catalogue Number: ER420
• Device Lot Number: U9493U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Date Manufacturer Received: 10/21/2020
• Patient Sequence Number: 1