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 second 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 had scissoring clips.The device was received for analysis on may 13, 2019.Upon receipt of the device it was observed there is significant biological contaminants in and around the entire distal portion of the device.The plastic shrouding was cracked and there was an observed gap between the 2nd and 3rd clip in the shaft.The push fork was out of position, up by the jaw as it has sunk into the shaft.There are nine (9) remaining clips in the device.The device's handle was actuated, but there was no movement of the compression spring and no advancement of the clips.No clip loaded into the jaw.While the handle will actuate, the internal mechanism that loads the clip into the jaws was damaged, and no longer functioning.As such, it is not possible to fire and evaluate any remaining clips for being malformed or scissoring.The account did not return any fired malformed clips for examination.Unable to duplicate or confirm the reported issue.Possible causes for the condition found may be if the device is 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.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: 8510431
• Report Number: 2134070-2019-00125
• Device Sequence Number: 11038973
• 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