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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

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GYRUS ACMI, INC 0.035" HYBRID WIRE, BOX OF 5 Back to Search Results
Model Number GWH3505R
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Uterine Perforation (2121)
Event Type  Injury  
Manufacturer Narrative
The user facility discarded the device after the procedure; therefore, no evaluation will be performed. As part of our investigation, olympus followed up with the user facility via telephone and in writing to obtain additional information regarding the reported event but with no result. The cause of the event cannot be determined at this time. This type of guidewire damage is most likely related to the operator's technique. The instruction manual contains several warning and caution statements in an effort to prevent damage to the guidewire. "do not apply excessive force to advance or withdraw the guidewire. If resistance is encountered, determine the cause and take remedial action before continuing. When using a moveable core guidewire, do not attempt to advance, stiffen or straighten the tip of the guidewire against resistance. Do not reshape or alter the configuration of the guidewire. Doing so may compromise the structural integrity of the guidewire and may result in complications. ".
 
Event Description
Olympus was informed that during a ureteroscopy procedure, while in the renal pelvis the physician was turning the guidewire and the patient¿s ureter was perforated. It was reported that prior to the perforation, the physician experienced difficulty with insertion due to the patient¿s anatomy. The intended procedure was completed with intervention. The patient¿s current condition is unknown.
 
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Brand Name0.035" HYBRID WIRE, BOX OF 5
Type of Device0.035" HYBRID WIRE
Manufacturer (Section D)
GYRUS ACMI, INC
ermsim schwoltbogen 24
dettingen, 72581 72581
GM 72581
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose, CA 95131
4089355124
MDR Report Key7937061
MDR Text Key122792546
Report Number2951238-2018-00609
Device Sequence Number1
Product Code EYA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGWH3505R
Device Catalogue NumberGWH3505R
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/04/2018 Patient Sequence Number: 1
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