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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 Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/20/2020
Event Type  malfunction  
Manufacturer Narrative
This event is under investigation.A supplemental report will be submitted upon receiving additional information.
 
Event Description
It was reported the user found the end of the hydrophilic floppy tip of the 0.035" hybrid wire was broken after the ureterolithotomy procedure.The procedure was completed with the device.No harm or impact to the patient was reported.
 
Manufacturer Narrative
This supplemental report is being submitted to provide the results of the manufacturer¿s investigation and additional information provided by the customer (see b5).The device evaluation, a review of the device history record (dhr), and a review of the instructions for use (ifu) were conducted during the investigation.The device evaluation confirmed the user report.The device was received by the customer in a small plastic bag, with no lot number listed, and the device was still coiled in the protective hoop.The inducer and the thumb advance inducer were not returned.The guidewire was examined, the only noted damage was noted at the hydrophilic distal tip.Approximately 2.5cm of the hydrophilic coating had come off of the device, this exposed the inner wire of the tip.The coating that had come off was not returned.The guidewire itself had some discoloration and debris on it consistent with procedural use.The lot number was unable to be confirmed.A review of the dhr for the possible lot numbers did not find any abnormalities or anomalies identified during production.The devices in the possible lots met all specifications upon release.The root cause could not be established.The ifu contains the following statement related to this event: -"the tips of some metal instruments may cause the coating material on the guidewire to be scraped off under conditions of sharp bending or kinking.If this occurs, it is recommended that any fragments of the outer coating material be removed.While advancing or withdrawing any coated guidewire, avoid sharply bending or kinking the portion of the guidewire that extends beyond the instrument." olympus will continue to monitor the field performance of this device.
 
Event Description
Additional information was received on 25jan2021.After the procedure, the user checked the condition of the patient with c-arm and there were no piece of broken tips which need to be retrieved.
 
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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 Key11174584
MDR Text Key240403225
Report Number3003790304-2021-00013
Device Sequence Number1
Product Code EYA
UDI-Device Identifier00821925031425
UDI-Public00821925031425
Combination Product (y/n)N
PMA/PMN Number
EXEMPT-EYA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 02/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
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? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/21/2020
Initial Date FDA Received01/14/2021
Supplement Dates Manufacturer Received01/28/2021
Supplement Dates FDA Received02/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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