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

Catalog Number	MSM20
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 11/19/2024.D4: batch # y70060.Additional information was requested and the following was obtained: "if you mentioned scissoring, were there any bleeding from the clips or additional procedures? no, there was no bleeding or additional procedures." investigation summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the msm20 device was received with a clip in jaws and with no apparent damage.In an attempt to replicate the reported incident, the device was tested for functionality.Upon testing, the device was cycled and it fed and formed twelve(12) malformed clip and then it ejected two(2) clips.In order to evaluate the condition of the device¿s internal components, the device was disassembled.Upon disassembling, the camplate was found to be broken causing the malformed and ejected clips.No conclusion could be reached as to what may have caused the reported incident.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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
Event or Problem Description
It was reported that during an unknown procedure, the clip was malformed at the first shot.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• Common Device Name: 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 20724399
• Report Number: 3005075853-2024-08770
• Device Sequence Number: 3783100
• Product Code: GDO
• UDI-Device Identifier: 10705036002505
• UDI-Public: (01)10705036002505(17)290131(10)Y70060
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K820837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/19/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: MSM20
• Device Lot Number: Y70060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown