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

Catalog Number ER320

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # r93u8f.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 2 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.A manufacturing record evaluation was performed for the finished device lot number r40p0w, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch number r93u8f, and no non-conformances were identified.

Event Description

It was reported that during a laparoscopic unknown procedure, the clip was fed into the jaws sideways during use.Another device was used to complete the case.There were no adverse consequences to the patient.

• 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: 8417961
• MDR Text Key: 138795411
• Report Number: 3005075853-2019-17232
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: ER320
• Device Lot Number: R40P0W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1