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

Catalog Number ER320

Device Problem Difficult to Open or Close (2921)

Patient Problems Blood Loss (2597); Not Applicable (3189); No Code Available (3191)

Event Date 10/08/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during a laparoscopic distal pancreatectomy, the jaws did not open after the firing on the splenic vein, and bleeding occurred while the surgeon tried to remove the device from the patient.After the jaws did not open at the firing on the splenic vein, another er320 was fired on the central side and the proximal end side of the splenic vein and the splenic vein was cut with a scissors to remove the er320 in question from the patient.At that time, massive bleeding occurred from the tip of the deployed clip.The amount of the bleeding was unknown and no blood transfusion was required.Then, the procedure was converted to open procedure for treatment of the damaged splenic vein.The operation video was checked and it was found that there was a possibility that the deployed clip was shorter than the width of the splenic vein.The surgeon did not attempt to use a larger clip or stapler on the vessel.Also, the sales rep checked and there were no malformed clips on the video and the surgeon said the handle was harder than usual.The patient is still hospitalized but getting well.

Manufacturer Narrative

(b)(4).Batch # t40a3w.Investigation summary: the er320 complaint device was received with no external damage.The device was visually inspected and it was observed that the jaws and handle were stuck closed with a formed clip and tissue between the jaws.The rotation knob was removed and the window of the knob shroud was peeled up to view the feeder plate and ensure that it was within the riding channel as appropriate.The feeder plate was confirmed to be within the riding channel on both handle halves.An attempt was made to fire the device in order to free the jaws from their stuck closed position but the trigger did not move.The trigger was then pulled open away from the handle and the trigger and jaws then returned to fully opened position, releasing the tissue and clip from inside the jaws.The formed clip was inspected and did not exhibit any scissoring or malformations.Another attempt was made to fire the device but the trigger was jamming internally in addition to jamming due to the dried blood/tissue in the jaws and shrouds which resulted in feeding/firing issues.The device was then disassembled and it was observed that there was damage to the handle half ramp due to gouging with the feeder link.In addition, the tail of the trigger was bent due to the handle gouging.The shaft/clip track was disassembled and 5 clips were found remaining (6 clips total including clip in jaws).It was able to be confirmed that the trigger jam and stuck jaws were the result of the handle gouging/bent trigger tail.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-conformance's were identified.

• 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: 9282064
• MDR Text Key: 185058228
• Report Number: 3005075853-2019-23257
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: ER320
• Device Lot Number: T40A3W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention