MAUDE Adverse Event Report: STERILMED, INC. CLIP APPLIERS LIGACLIP MULTIPLE CLIP APPLIERS LG CLIPS; CLIP, IMPLANTABLE, REPROCESSED

Model Number	ETHMCL20
Medical Device Problem Codes	Failure to Fire (2610); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been reported as not available for return.The following reports are related to the same event: 2134070-2021-00034, 2134070-2021-00035, and 2134070-2021-00036.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a (b)(6), male, patient underwent a laparoscopic open cholecystectomy procedure with four reprocessed clip appliers ligaclip and during the procedure, the four clip appliers failed to fire.A fifth clip was used and worked as expected.There was no patient consequence.
Additional Manufacturer Narrative
It was originally reported that a 56-year-old, male, patient underwent a laparoscopic open cholecystectomy procedure with four reprocessed clip appliers ligaclip and during the procedure, the four clip appliers failed to fire.Additional information was received 17-dec-2021 that the issue was the clips did not advance/feed and not a failure to fire.In addition, there was no problem with how the clips formed.With the additional information received, this event has been reassessed as a not mdr reportable event.Manufacturer's ref.No: (b)(4).

• Brand Name: CLIP APPLIERS LIGACLIP MULTIPLE CLIP APPLIERS LG CLIPS
• 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: 13025833
• Report Number: 2134070-2021-00033
• Device Sequence Number: 1766019
• Product Code: NMJ
• UDI-Device Identifier: 10888551019057
• UDI-Public: 10888551019057
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2021

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: 11/18/2021
• Device Model Number: ETHMCL20
• Device Catalogue Number: ETHMCL20
• Device Lot Number: 2142377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 108 KG