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

Catalog Number ETHMCS20

Device Problem Failure to Fire (2610)

Patient Problem Blood Loss (2597)

Event Date 06/06/2018

Event Type  Injury  

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.We are working on the device history record (dhr), once we get more information it will be submitted in a supplemental.(b)(4).

Event Description

A user facility report was received from the fda that reported a clip applicator was not firing properly as the clips were not loading up and firing.In addition, on the user facility, the event type of serious injury was checked and event outcome of required intervention was also checked.However, there was no further information on this serious injury as well as no contact information to gain further clarification.Therefore, to be conservative sterilmed is reporting this event as a bleeding event as that is our assumption of the event.

Manufacturer Narrative

Additional information was received on july 20, 2018.Device history record review was conducted.No discrepancies noted.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
• MDR Report Key: 7705090
• MDR Text Key: 114538374
• Report Number: 2134070-2018-00105
• Device Sequence Number: 1
• Product Code: NMJ
• UDI-Device Identifier: 10888551019088
• UDI-Public: 10888551019088
• Combination Product (y/n): N
• PMA/PMN Number: K033579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2018
• Device Catalogue Number: ETHMCS20
• Device Lot Number: 2029384
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention