MAUDE Adverse Event Report: STERILMED, INC. MULTIPLE CLIP APPLIER LIGACLIP; CLIP, IMPLANTABLE, REPROCESSED

Model Number	ETHMCM30
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product analysis lab received the device for evaluation.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacture report numbers 2134070-2021-00025 are related to the same event.(b)(4).
Event or Problem Description
It was reported that a patient underwent a breast lumpectomy with two reprocessed multiple clip applier ligaclips and when clip applier fired it did not close on tissue.A new non-reprocessed device was used to complete the procedure.The intent of the procedure was not altered because of this event.There was no patient consequence.
Additional Manufacturer Narrative
It was reported that a patient underwent a breast lumpectomy with a reprocessed multiple clip applier ligaclips and when clip applier fired it did not close on tissue.The returned device was received inside a sealed plastic biohazard bag, with none of the original packaging or labeling returned.There are no fired clips from this device provided as well.It was observed that the device was marked for (b)(6) clips being sent to the customer.However, the device has been returned with the yellow tab fully forward and the locking mechanism engaged.There are no remaining clips.All (b)(6) clips have been fired from this device.As there are no remaining clips and the handle is locked, the firing capability of the device cannot be observed.The jaws of the device appear properly spaced and aligned.There are no observed visual defects with the device.There was no additional evidence provided showing the condition of the fired clips from this device.As there was no evidence of a defect with this device, the reported issue was not confirmed.As product was removed from its packaging and was used by the account, no conclusion as to the cause of the reported issue is determined.The device history record of lot 2153586 was reviewed and all finished goods products reprocessed under this lot passed all visual and functional criteria prior to being distributed to the customer.No failure was observed on the device.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

• Brand Name: MULTIPLE CLIP APPLIER LIGACLIP
• Common Device Name: CLIP, IMPLANTABLE, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer (Section G): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12852304
• Report Number: 2134070-2021-00026
• Device Sequence Number: 19834937
• Product Code: NMJ
• UDI-Device Identifier: 10888551019071
• UDI-Public: 10888551019071
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K033579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2021

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 Expiration Date: 08/05/2022
• Device Model Number: ETHMCM30
• Device Catalogue Number: ETHMCM30
• Device Lot Number: 2153586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown