• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

  • 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
 

AIZU OLYMPUS CO., LTD. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE Back to Search Results
Model Number GIF-HQ190
Device Problems Break (1069); Unintended System Motion (1430); Use of Device Problem (1670)
Patient Problem Cardiac Arrest (1762)
Event Date 07/15/2022
Event Type  Injury  
Event Description
The customer reported, during an emergency with the patient, the subject device was physically damaged at the connector.The connector was cracked open and wires were exposed.No endoscope malfunction during use, no patient harm reported, the procedure was successfully completed and no procedural delay.Although no harm was reported, the chain of events is unclear and this is being submitted conservatively as a serious injury and reportable malfunction.Initially, the customer reported the patient was in cardiac arrest during the procedure but the nurse involved later clarified the endoscope was damaged when the patient was taken to interventional radiology (ir).When the patient needed the ir procedure and was hurried out of the room, the nurse packed up the travel cart, failed to unplug the power cord from the wall and failed to disconnect the scope from the processor.The nurse believes the plug must have pulled from the wall and dragged behind the travel cart.Also, the plug got caught on something because it jerked the travel cart to a stop and the endoscope was thrown from the cart and crushed between the doors to the endoscopy unit.The scope was thrown from the cart and was crushed between the doors to the endo unit.The damage to the endoscope was extensive and allowed no way for the scope to be submerged for proper manual cleaning.It was also clear the scope could not be placed in the medivator machine for high level disinfection.The rn wiped the scope down using the proper ¿pre-clean¿ process, wiping the best she could, place it in a scope bag and leave it in the decontamination room.The customer contacted olympus and the olympus representative further advised the endoscope, in the bag should be placed in a hard contacting for pick up on 18jul2022.An intensive travel cart training practices and care of endoscopes was provided to the nurse involved and the endoscopy staff.The training involved the set-up, break down, safety issues, supplies/inventory, and driving the cart to/from both the icu and the or.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Type of Device
GASTROINTESTINAL VIDEOSCOPE
Manufacturer (Section D)
AIZU OLYMPUS CO., LTD.
3-1-1 niiderakita
aizuwakamatsu-shi, fukushima 965-8 520
JA  965-8520
MDR Report Key15698937
MDR Text Key302694842
Report Number2429304-2022-00105
Device Sequence Number1
Product Code FDS
UDI-Device Identifier04953170305276
UDI-Public04953170305276
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 07/20/2022,10/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberGIF-HQ190
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/22/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date07/20/2022
Event Location Hospital
Date Report to Manufacturer07/20/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-