FDA Adverse Event Malfunction Summary report: N

ULTRA-CATCH NT (1.8 FRX 115 CM) STONE RETRIEVAL DEVICE

MDR report key: 5274174 · Received December 8, 2015

Report

Report Number: 2183680-2015-00005
Event Type: Malfunction
Date Received: December 8, 2015
Date of Event: November 19, 2015
Report Date: December 8, 2015
Manufacturer: GYRUS ACMI, INC.
Product Code: FGO
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

AT THE TIME OF THIS REPORT, THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFORMATION BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

Description of Event or Problem · 1

GYRUS ACMI WAS INFORMED THAT DURING THE TUL PROCEDURE, THE INSERTION PORTION OF THE STONE RETRIEVAL DEVICE AND URETEROSCOPE (B)(4) GOT STUCK WITHIN THE URETER WHEN THE FACILITY TRIED TO RETRIEVE THE FRAGMENTS OF THE STONE AFTER GRASPING THE STONE WITH THE BASKET. SINCE THE RETRIEVAL OF THE STONE WAS NEARLY COMPLETED, THE FACILITY REPORTEDLY FINISHED THE PROCEDURE AFTER CUTTING THE DISTAL PORTION OF THE STONE RETRIEVAL DEVICE AND LEFT THE INSERTION PORTION OF THE SUBJECT DEVICE AND THE URETEROSCOPE (B)(4). THE DAY AFTER THE PROCEDURE, THE STONE RETRIEVAL DEVICE AND THE URETEROSCOPE (B)(4 )REPORTEDLY WERE RETRIEVED BY HOLDING AND WITHDRAWING THE PART OF THE SUBJECT DEVICE WHICH CAME OUT OF THE PATIENT. (WITHOUT ADDITIONAL ENDOSCOPIC PROCEDURE OR SURGERY) ALTHOUGH THE PATIENT STAYED IN THE HOSPITAL AFTER THE PROCEDURE, THE PATIENT IS REPORTEDLY DOING WELL. THERE WAS NO PATIENT INJURY REPORT RELATED TO THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
805287	ULTRA-CATCH NT (1.8 FRX 115 CM) STONE RETRIEVAL DEVICE	STONE RETRIEVAL DEVICE	FGO	GYRUS ACMI, INC.	NT4W18115	MK901616

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| O