MAUDE Adverse Event Report: STERILMED, INC. MULTI CLIP APPLIER LIGACLIP SMALL CLIPS; CLIP, IMPLANTABLE, REPROCESSED

Model Number ETHMCS20

Device Problems Failure to Fire (2610); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/05/2021

Event Type  malfunction  

Manufacturer Narrative

The device has been reported as not available for return.The following reports are related to the same event: 2134070-2021-00033, 2134070-2021-00034, 2134070-2021-00035 and 2134070-2021-00036.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's ref.No: (b)(4).

Event 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.

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: MULTI CLIP APPLIER LIGACLIP SMALL CLIPS
• Type of Device: 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: 13025788
• MDR Text Key: 282401794
• Report Number: 2134070-2021-00035
• Device Sequence Number: 1
• Product Code: NMJ
• UDI-Device Identifier: 10888551019088
• UDI-Public: 10888551019088
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2022
• Device Model Number: ETHMCS20
• Device Catalogue Number: ETHMCS20
• Device Lot Number: 2153678
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 108 KG