MAUDE Adverse Event Report: STERILMED, INC.; CLIP, IMPLANTABLE, REPROCESSED

Model Number	ETHMCM30
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The reprocessed ligaclip failed.The physician tried to control bleeding with clip applier.The reprocessed clip applier was not functioning correctly and a brand new clip applier was opened.

• Brand Name: NA
• Common Device Name: CLIP, IMPLANTABLE, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire pkwy n ste 2; plymouth MN 55446
• MDR Report Key: 8645209
• Report Number: 8645209
• Device Sequence Number: 2017459
• Product Code: NMJ
• UDI-Device Identifier: 10888551019071
• UDI-Public: (01)10888551019071(17)201191008(10)2058827
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/15/2019
• Report Date (Section F): 05/15/2019

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 Model Number: ETHMCM30
• Device Catalogue Number: ETHMCM30
• Device Lot Number: 2058827
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/28/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/28/2019
• Patient Sequence Number: 1
• Date Report Sent to FDA: 05/15/2019