Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLACK DIAMOND VIDEO INTEGRATED DIGITAL SURGICAL RACK
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BLACK DIAMOND VIDEO INTEGRATED DIGITAL SURGICAL RACK Back to Search Results
Device Problems Device Emits Odor (1425); Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/27/2020
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite to inspect the integrated digital surgical rack and discovered that there was damage to an amplifier on one of the circuit boards.The damage was contained within the unit.The technician replaced the amplifier, tested the unit, found it to be operating according to specifications, and returned it to service.The amplifier will be returned for further evaluation.A follow-up mdr will be submitted should additional information becomes available.
 
Event Description
The user facility reported that their integrated digital surgical rack was emitting a burning smell during procedure preparation.Upon opening the rack, a small amount of smoke was observed.No patient was present.No delay or report of injury.
 
Manufacturer Narrative
The amplifier was evaluated by the oem and a root cause could not be determined.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INTEGRATED DIGITAL SURGICAL RACK
Type of Device
DIGITAL SURGICAL RACK
Manufacturer (Section D)
BLACK DIAMOND VIDEO
503 canal blvd.
richmond CA 94804
MDR Report Key10583445
MDR Text Key208801422
Report Number3008776287-2020-00004
Device Sequence Number1
Product Code FTA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 09/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Date Manufacturer Received08/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-