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

Model Number ER420

Device Problems Failure to Fire (2610); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: u93z6p.Investigation summary: the analysis results found that the er420 device was returned with no apparent damage, with a clip in the jaws.Three open clips and three conforming clips were also returned inside of a plastic bag.The device was tested for functionality and during the analysis the device was cycled and it fed, retained, and formed the remaining eleven 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: fully squeeze the trigger and then release to load the first clip into the instrument jaws.Failure to completely squeeze the trigger can result in clip mis-loading.Position the jaws with the clip completely around the vessel to be ligated.Fully squeeze the trigger on each firing.Do so by pulling back on the trigger even after a sharp ¿click¿ is heard and until you touch plastic trigger to plastic handle (plastic to plastic).Fully release the trigger after firing.A second ¿click¿ should be heard indicating the instrument is ready for the next firing.The next clip is automatically advanced as the trigger is released.Inspect the instrument jaw tips after each use to ensure a new clip is present before the next firing." 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.

Event Description

It was reported that during a laparoscopic cholecystectomy, the surgeon felt the handle could not be grasped fully during use.The two clips were fed at the same time.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10840206
• MDR Text Key: 216410962
• Report Number: 3005075853-2020-06006
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/29/2020

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: ER420
• Device Catalogue Number: ER420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Date Manufacturer Received: 10/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1