MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES DRAPE ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 100773

Device Problems Defective Device (2588); Contamination /Decontamination Problem (2895)

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

Event Date 07/11/2013

Event Type  malfunction  

Event Description

It was reported that during setup of monitor drape, unpeeling the protective cover would cause the cover to tear as if stuck on the monitor interface material rendering the drape unusable as a sterile barrier. 4 out of 8 drapes had this problem. During procedure the functional drapes were used. There was no surgical delay reported.

• Brand Name: DRAPE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd; suite 40; plymouth, mn
• Manufacturer Contact: rick confer ; 2828 liberty ave; suite 100; pittsburgh, pa
• MDR Report Key: 9994115
• MDR Text Key: 188842806
• Report Number: 3010266064-2020-00110
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 100773
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/17/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse