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

Catalog Number	ETHMSM20
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sterilmed failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).
Event or Problem Description
It was reported that a patient underwent a procedure with a clip appliers ligaclip multiple clip appliers lg clips and the clips did not fire correctly which caused the vessel to be severed.During the procedure, during use of the device the damage of the vessel was identified immediately.The patient¿s vessel was repaired and extended hospitalization was not required.The patient has since fully recovered.The physician¿s opinion on the cause of the adverse event is that it was due to product malfunction.
Additional Manufacturer Narrative
The account returned 1 ethmsm20 stating that, "clips did not fire correctly" and that during the procedure the vessel was severed.The device was examined and subjected to full visual and functional testing.Outside of the presence of contaminants consistent with patient contact and use in the field, the device passed its visual inspection.The jaws were in alignment and the clip retainer was in position.The functionality of the device was tested via firing the device.The device was shipped to the field with 17 clips for use as noted by the number written in ink on the handle.The device was returned with 8 clips remaining.The device fired all 8 remaining clips, producing clips off appropriate pinch and alignment without interruption until all clips were spent.No defect was displayed by the device, nor were any of the clips found to displaying any features that would result in an injury.Based on this evidence the account's complaint could not be duplicated nor confirmed.A device history record review was performed, and no discrepancies were noted.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: 7627397
• Report Number: 2134070-2018-00104
• Device Sequence Number: 1818364
• Product Code: NMJ
• UDI-Device Identifier: 10888551019095
• UDI-Public: 10888551019095
• Combination Product (Y/N): N
• PMA/510(K) Number: K033579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ETHMSM20
• Device Lot Number: 2037507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 06/21/2018
• Supplement Report FDA Received Date: 07/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention