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

Model Number ER320

Device Problem Failure to Fire (2610)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Event Description

It was reported that during an adrenalectomy procedure, when doctor used device, the first clip was applied, but when surgeon wanted to apply the second clip, the clip didn¿t apply, no clip appeared in the jaw, so surgeon used the other like device to complete the surgery.Procedure was successfully completed and there was no patient consequence.

Manufacturer Narrative

(b)(4).Batch # u95l2v.Date of event is 2021.No event day or event month was provided.(b)(4).Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Upon visual analysis of the returned sample, it was determined the er320 device was returned with a clip between jaws and the lower shroud.In addition, the tyvek wrapper was also returned along with the instrument.The clip was manually removed and in an attempt to replicate the reported incident, the device was tested for functionality.Upon testing, the retaining clip was not properly fed into the jaws causing the clip to be ejected.Upon further analysis, it was noted that the lower shroud was damaged causing the feeding issue.In addition, nineteen clips were observed inside the clip track, however, no conclusion could be reached as to what caused the damage observed.Although no conclusion could be reached on the cause of the reported event, the instructions for use 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." as part of our quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is 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.

• 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 ; *
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 13006636
• MDR Text Key: 286748294
• Report Number: 3005075853-2021-07729
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012580
• UDI-Public: 10705036012580
• Combination Product (y/n): N
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ER320
• Device Catalogue Number: ER320
• Device Lot Number: U40R2E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1