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

Model Number ER320

Device Problems Failure to Form Staple (2579); Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: t94133.Investigation summary: the er320 device was returned for analysis and upon inspection, the jaws 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, the remaining 11 clips were ejected due to the condition of the jaws; finally, the instrument locked out as intended.The reported complaint was confirmed.Possible causes for the found condition of the yielded jaws may be due to 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.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.Please reference the instruction for use for more information.It should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.Attempts are being made to obtain the following information.To date no response has been provided.If the further details are received at a later date, a supplemental medwatch will be sent: was there any patient consequence? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during a sleeve gastrectomy, there was jamming in the clip jaw without being bended.After several shots all the clips stayed in the jaw and got jammed.The clips were malformed.They did not close properly causing them to stack on top of each other inside the jaws of the clip gun.It is unknown how procedure was completed.Patient consequence was not reported.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10796467
• MDR Text Key: 215083705
• Report Number: 3005075853-2020-05797
• 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
• Report Date: 10/11/2020

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: ER320
• Device Catalogue Number: ER320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Manufacturer Received: 10/11/2020
• Initial Date FDA Received: 11/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1