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

Catalog Number	ETHMCS20
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for return, however has not yet been returned.We are working on obtaining manufacturing record evaluation, once we get more information it will be submitted in the supplemental.The following report numbers are related to the same event: 2134070-2019-00124, 2134070-2019-00125, 2134070-2019-00126.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent a procedure with two multi clip applier ligaclip small clips and one multiple clip applier ligaclip mca and all of the devices has scissoring clips.The devices were exchanged to complete the procedure.The intent of the procedure was not altered as a result of this event.There was no patient injury or consequence.No further information has been made available.This report is for the first of the two multi clip applier ligaclip small clips.
Additional Manufacturer Narrative
It was reported that a patient underwent a procedure with a multi clip applier ligaclip small clips and the device has scissoring clips.The device was returned for analysis on may 13, 2019.Upon receipt of the device it was observed that the jaw appears damaged and yielded.The clip retainer and part of the push fork are bent outwards and are also out of position.The plastic shroud was lifted and cracked in twain.There were significant biological contaminants in and around the entire distal portion of the device.As well, there are no remaining clips in the returned device, originally sent to the account with 13 clips.The yellow tab is fully forward, and the handle's locking mechanism is locked and no longer actuates.For this, it was not possible to test and evaluate the device for scissoring clips.The account did not return any fired, malformed clips for examination and verification.As the device was removed from its packaging and used in the procedure - where all clips have been fired - no conclusion can be determined as to the cause of the reported issue.Possible causes for the condition found may be if the device was 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, the resulting stresses damaging the device.A manufacturing record evaluation was performed for the reported device lot# 2071732, and no internal actions were identified.The reported issue is not confirmed.Manufacturer's ref.No: (b)(4).

• Brand Name: MULTI CLIP APPLIER LIGACLIP SMALL CLIPS
• Common Device Name: CLIP, IMPLANTABLE, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 8510434
• Report Number: 2134070-2019-00124
• Device Sequence Number: 19321624
• Product Code: NMJ
• UDI-Device Identifier: 10888551019088
• UDI-Public: 10888551019088
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K033579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2019

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: 09/12/2019
• Device Catalogue Number: ETHMCS20
• Device Lot Number: 2071732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1