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

Catalog Number	ETHMSM20
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
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.Since no lot number was provided, no manufacturing record evaluation review could be performed.The following report numbers are related to the same event: 2134070-2019-00124, 2134070-2019-00125, 2134070-2019-00126.(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 multiple clip applier ligaclip mca.
Additional Manufacturer Narrative
It was reported that a patient underwent a procedure with a multiple clip applier ligaclip mca and the device had scissoring clips.The device was received for analysis on may 13, 2019.Upon receipt of the device, it was visually and functionally examined.There were biological contaminants on all parts of the device, including the jaw area.There were only two clips remaining; as the device was marked as being sent with 14 clips.It was determined that twelve (12) clips were actuated and fired at the account.The account did not return any fired, malformed clips for examination.The device was actuated, and it fired the two remaining clips, with the proper speed, pinch and alignment.There were no discrepancies observed in the functionality and operation of the returned device.Unable to duplicate the reported issue.As no lot number was provided, no manufacturing record evaluation could be conducted.Manufacturer's ref.No: (b)(4).

• Brand Name: MULTIPLE CLIP APPLIER LIGACLIP MCA
• Common Device Name: CLIP, IMPLANTABLE, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 8510416
• Report Number: 2134070-2019-00126
• Device Sequence Number: 1471301
• Product Code: NMJ
• UDI-Device Identifier: 10888551019095
• UDI-Public: 10888551019095
• 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 Catalogue Number: ETHMSM20
• 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