MAUDE Adverse Event Report: KEY SURGICAL KEY SURGICAL VASCULAR LOOPS

Model Number	VL-206
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A root cause of the complaint could not be determined.The end user did not provide answers to the key surgical requests for further information to assist with the complaint investigation.It cannot be determined if the root cause is due to end user error or a device manufacturing, storage or distribution concern.A broken loop is easily recognizable to the end user and would not be used if observed.The end user did not provide any insight into their storage or specific use of the loop prior to it breaking.The loop met all manufacturer and key surgical acceptance criteria prior to it being sent to the field.The occurrence rate of a broken loop over 20+ years of distribution is remote, and there has not been any reports of patient harm to date out of (b)(4) boxes of loops sold.
Event or Problem Description
Key surgical received fda medwatch report mw5096967 on october 29, 2020.The report stated that an 18" blue maxi vascular loop (determined by key surgical to be vl-206) broke into three pieces during surgery.The loop was placed into patient's abdomen and broke into 3 pieces.Two pieces were easily retrieved and the third piece was found in the filter of the neptune suction.

• Brand Name: KEY SURGICAL VASCULAR LOOPS
• Common Device Name: VASCULAR LOOP
• Manufacturer (Section D): KEY SURGICAL; 8101 wallace road; eden prairie MN 55344
• MDR Report Key: 10905047
• Report Number: 2183785-2020-00003
• Device Sequence Number: 19078094
• Product Code: KDC
• UDI-Device Identifier: 00849771030881
• UDI-Public: 00849771030881
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/07/2024
• Device Model Number: VL-206
• Device Catalogue Number: VL-206
• Device Lot Number: 099383
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1