MAUDE Adverse Event Report: MEDIVATORS INC. MEDIVATORS SCOPE BUDDY PLUS TUBING; ACCESSORIES, CLEANING, FOR ENDOSCOPE

Model Number SB-110-HU1007

Device Problem Contamination (1120)

Patient Problem Insufficient Information (4580)

Event Date 08/06/2021

Event Type  malfunction  

Event Description

There is clearly visible contamination/ residue present on the tubing clamp area, that was present upon opening the package of medivators scope buddy plus tubing.Fda safety report id# (b)(4).

• Brand Name: MEDIVATORS SCOPE BUDDY PLUS TUBING
• Type of Device: ACCESSORIES, CLEANING, FOR ENDOSCOPE
• Manufacturer (Section D): MEDIVATORS INC.
• MDR Report Key: 12307052
• MDR Text Key: 266210001
• Report Number: MW5103144
• Device Sequence Number: 1
• Product Code: FEB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/06/2021

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
• Device Operator: Health Professional
• Device Model Number: SB-110-HU1007
• Device Catalogue Number: SB-110-HU1007
• Device Lot Number: 493928
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2021
• 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