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

Catalog Number ER320

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a laparoscopic gastrectomy, the trigger did not return to home position after the firing on the blood vessel.The central side of the target tissue was clipped with another er320, and the device in complaint was removed from the patient.Another er320 was used to complete the case.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).Batch # t92l3z.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 to be bent, not allowing the clips to be fed into the jaws.In addition, 20 clips were found to be remaining inside the clip track.The damage on the device could be caused by 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: 9182734
• MDR Text Key: 202729834
• Report Number: 3005075853-2019-22742
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2024
• Device Catalogue Number: ER320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Date Manufacturer Received: 11/05/2019
• Patient Sequence Number: 1