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

Catalog Number ER320

Device Problems Unintended Ejection (1234); Failure to Form Staple (2579)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # t92k0d.Investigation summary: the analysis results found that 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 12 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 caused by the device being 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 is known from the history of the device that the condition of the jaws may lead dropping/ejected clips.A manufacturing record evaluation was performed for the finished device lot/batch number and no non-conformances were identified.

Event Description

It was reported that during a laparoscopic cholecystectomy, each time the user fired the ligaclip, the clips came out open and where spread around into the abdomen.The clips were ejected from the jaws of the device on the tissue "open." the surgery was completed with a covidien endoclip device.There was no patient consequence.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 9264720
• MDR Text Key: 199877833
• Report Number: 3005075853-2019-23143
• 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: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: ER320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Date Manufacturer Received: 10/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1