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

Catalog Number	ETHMCS20
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	06/06/2018
Type of Reportable Event	Serious Injury
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.We are working on the device history record (dhr), once we get more information it will be submitted in a supplemental.(b)(4).
Event or Problem 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.
Additional 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
• Common Device Name: CLIP, IMPLANTABLE, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 7705090
• Report Number: 2134070-2018-00105
• Device Sequence Number: 1404917
• Product Code: NMJ
• UDI-Device Identifier: 10888551019088
• UDI-Public: 10888551019088
• 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: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2018

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 Expiration Date: 11/10/2018
• Device Catalogue Number: ETHMCS20
• Device Lot Number: 2029384
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 07/20/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention