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

Model Number ER420

Device Problems Unintended Ejection (1234); Failure to Form Staple (2579); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Attempts were being made to obtain the following additional information: can you please clarify the portion of the event where "the device when placed on the staple line was dislodging clips"? were clips falling out of the jaws of the device hence the term "dislodging clips"? or was the device itself dislodging clips that had been previously placed (meaning clips would not hold on the staple line)? to date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that during a sleeve gastrectomy, the device, when placed on the staple line, was dislodging clips.The clips were not closing completely and were falling out of the jaws.Case completed with another device of the same product code.There were no patient consequences reported.

Manufacturer Narrative

(b)(4).Date sent: 4/2/2020.D4: batch # t94x9m.Investigation summary: the er420 device was returned for analysis and upon inspection of the jaws, they 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, 3 clips were ejected due to the condition of the jaws.In order to evaluate the condition of the internal components of the device, it was disassembled.Upon disassembling, no anomalies were found, and 12 clips were remaining in the clip track.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 batch number, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 3/10/2020.H2: additional information received from customer: "what i explained to rep was the staplers usually take 1 click to load and another one to firing, but these were taking only 1 to fire which was a malfunction.Frank stated he was not aware of any changing of the er420.The patient¿s stomach line was bleeding and the patient did not need additional clips exiting the stapler (for which the surgeon needed to eventually find them), but needed the stapler to work as it had in the past.One to click and one to staple.".

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9801166
• MDR Text Key: 200663960
• Report Number: 3005075853-2020-01491
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012597
• UDI-Public: 10705036012597
• 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,Followup
• Report Date: 02/13/2020

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 Model Number: ER420
• Device Catalogue Number: ER420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Initial Date Manufacturer Received: 02/13/2020
• Initial Date FDA Received: 03/06/2020
• Supplement Dates Manufacturer Received: 02/27/2020; 03/17/2020
• Supplement Dates FDA Received: 03/10/2020; 04/02/2020
• Patient Sequence Number: 1