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

Model Number ER320

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.

Event Description

It was reported that during a lap chole, the jaws were stuck shut after firing a clip and removing from the patient.It is unknown how the case was completed.There were no patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 1/31/2020.D4: batch # t9298l.Investigation summary: the analysis results found that an er320 device was received with the trigger closed.The device was disassembled to evaluate the condition of the internal components and the trigger was found broken, not allowing the clips to fed into the jaws.In addition, 18 clips were found remaining inside the clip track.The damage on the device could be due to the internal ribs being gauged by the feeder link, causing the trigger to experience additional force that could interfere with the firing of the device.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
• MDR Report Key: 9495610
• MDR Text Key: 182975549
• Report Number: 3005075853-2019-24586
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2024
• Device Model Number: ER320
• Device Catalogue Number: ER320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Date Manufacturer Received: 01/13/2020
• Patient Sequence Number: 1