MAUDE Adverse Event Report: GYRUS ACMI, INC 0.035" HYBRID WIRE, BOX OF 5

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.

• Brand Name: 0.035" HYBRID WIRE, BOX OF 5
• Type of Device: 0.035" 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 Key: 7937061
• MDR Text Key: 122792546
• Report Number: 2951238-2018-00609
• Device Sequence Number: 1
• Product Code: EYA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GWH3505R
• Device Catalogue Number: GWH3505R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2018
• Initial Date FDA Received: 10/04/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention