MAUDE Adverse Event Report: STERILMED, INC. MULTI CLIP APPLIER LIGACLIP ERCA ROTATING MEDIUM/LARGE CLIPS; CLIP, IMPLANTABLE, REPROCESSED

Catalog Number	ETHER320
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned on january 23, 2018 and was examined and subjected to full functional testing.The device was fired, loading properly and producing clips of proper pinch and alignment.No defect was found with the device's functionality.No malformed or misaligned clips were produced.Based on these findings, the complaint could not be confirmed.No lot number was provided in order to conduct a review of the device history record.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent an unknown procedure with a multi clip applier ligaclip erca rotating medium/large clips and a clip malformation occurred.There was no patient consequence.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

• Brand Name: MULTI CLIP APPLIER LIGACLIP ERCA ROTATING MEDIUM/LARGE CLIPS
• Common Device Name: CLIP, IMPLANTABLE, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 8901853
• Report Number: 2134070-2019-00142
• Device Sequence Number: 2206157
• Product Code: NMJ
• UDI-Device Identifier: 10888551018937
• UDI-Public: 10888551018937
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/27/2017

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: ETHER320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 08/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1