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: TELEFLEX MEDICAL RUSCH MRI COND FIBER OPTIC LARYN KIT; LARYNGOSCOPE, RIGID
  • 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
 

TELEFLEX MEDICAL RUSCH MRI COND FIBER OPTIC LARYN KIT; LARYNGOSCOPE, RIGID Back to Search Results
Catalog Number 005852300
Device Problem Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/11/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that "after four weeks of use the battery was empty and when shaking it is noticeable that the battery is moving in the inner part, it is not tight." the alleged issue was detected prior to patient use.No patient involvement reported.
 
Manufacturer Narrative
Qn# (b)(4).The device was returned and sent to the manufacturing site for evaluation.The manufacturing site reports "the device history record of lot 170301 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification." it was also reported that "battery cartridge is found out of warranty period and exceeded the self-life of 18 months at the time of complaint reported.Further to investigate, we have confirmed that reported failure was not confirmed because received complaint sample of battery cartridge is working fine.We have performed the functional testing of battery cartridge with mri handle and noticed that battery cartridge is working fine.".
 
Event Description
It was reported that "after four weeks of use the battery was empty and when shaking it is noticeable that the battery is moving in the inner part, it is not tight." the alleged issue was detected prior to patient use.No patient involvement reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RUSCH MRI COND FIBER OPTIC LARYN KIT
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key10944481
MDR Text Key219513374
Report Number8030121-2020-00163
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 11/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number005852300
Device Lot Number170301
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2020
Date Manufacturer Received12/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-