MAUDE Adverse Event Report: KEY SURGICAL LLC VASCULAR LOOPS, BLUE, MAXI 18" LENGTH; INSTRUMENT, SURGICAL, DISPOSABLE

Lot Number 099382

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/22/2020

Event Type  malfunction  

Event Description

Key surgical vascular loop broke into 3 pieces during surgery.A maxi blue vessel loop was placed in pt'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: VASCULAR LOOPS, BLUE, MAXI 18" LENGTH
• Type of Device: INSTRUMENT, SURGICAL, DISPOSABLE
• Manufacturer (Section D): KEY SURGICAL LLC
• MDR Report Key: 10606107
• MDR Text Key: 209450563
• Report Number: MW5096967
• Device Sequence Number: 1
• Product Code: KDC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2024
• Device Lot Number: 099382
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 80