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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI, INC 0.035" HYBRID WIRE, BOX OF 5; STYLET, URETERAL
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GYRUS ACMI, INC 0.035" HYBRID WIRE, BOX OF 5; STYLET, URETERAL Back to Search Results
Model Number GWH3505R
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
 
Event Description
It is reported during an unspecified procedure using a 0.035" hybrid wire, the device was torn when pulled out of the patient (broke outside of the patient).There was no patient impact related to this occurrence.
 
Manufacturer Narrative
This report is being updated to provide investigation findings.The device history record (dhr) for the complaint device could not be reviewed since the lot number was not provided.Olympus does not ship any device that does not meet all design and safety specifications.Conclusion: the definitive cause of the reported events could not be established.
 
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Brand Name
0.035" HYBRID WIRE, BOX OF 5
Type of Device
STYLET, URETERAL
Manufacturer (Section D)
GYRUS ACMI, INC
136 turnpike road
southborough MA 01772
MDR Report Key11829591
MDR Text Key257391306
Report Number3003790304-2021-00089
Device Sequence Number1
Product Code EYA
UDI-Device Identifier00821925031425
UDI-Public00821925031425
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberGWH3505R
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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