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

Catalog Number ER320

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Attempts have been made to obtain additional information and to retrieve the device: can you please clarify what was done to address the tear in the stomach tissue? were there any patient consequences? was there any change in the post-operative care of the patient due to the event that occurred? if yes, please describe.To date, no response has been provided and the device has not been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.

Event Description

It was reported that during an unknown procedure, the devices clipped the stomach but didn't let go of the stomach tissue.The shaft of the clip didn't navigate and it didn't let the tissue go but it tore the stomach.

Manufacturer Narrative

(b)(4).Batch # t92a11.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 bent, not allowing the clips to fed into the jaws.In addition, 20 clips were found remaining inside the clip track.The damage on the device could be that the internal ribs were 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.

Manufacturer Narrative

(b)(4).Date sent: 1/17/2020.H10=corrected data=h10 investigation summary.H10: investigation summary: possible causes for the found condition of the yielded jaws could be due to the device being closed over an existing hard object or clip, thus placing stress on the jaws and causing them to distort or yield and not return to their original dimensions/position, or the excessive application of torque to the jaws when positioning the device on a vessel.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9257922
• MDR Text Key: 198538059
• Report Number: 3005075853-2019-23079
• 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,Followup
• Report Date: 10/02/2019

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: 01/08/2024
• Device Catalogue Number: ER320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: 12/04/2019; 12/27/2019
• Supplement Dates FDA Received: 12/20/2019; 01/17/2020
• Patient Sequence Number: 1