STORZ 27074 B *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-11-26 for STORZ 27074 B * manufactured by Storz.

Event Text Entries

[31868] Physician was using the stone crusher (number 18 noted on the handle), the equipment malfunctioned and remained in the open position. The physician performed a urethral meatotomy and was able to remove the instrument. A second stone crusher was obtained (number 25 noted on the handle). During the procedure the instrument broke. The x-ray showed that the jaws were open and actually had a 90% angle up. Attempts were made to try to close the jaws, as discussed with the co. The physician was not able to retrieve the instrument. A midline incision was made. A piece of stone was removed, the stone crushing forceps were straightened and able to be removed through the sheath.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	52488
MDR Report Key	52488
Date Received	1996-11-26
Date of Report	1996-11-26
Date of Event	1996-11-20
Date Added to Maude	1996-12-03
Event Key	0
Report Source Code	User Facility report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	0
Reporter Occupation	RISK MANAGER
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	STORZ
Generic Name	STONE CRUSHER
Product Code	FGK
Date Received	1996-11-26
Model Number	27074 B
Catalog Number	*
Lot Number	*
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	Y
Device Age	*
Implant Flag	N
Date Removed	*
Device Sequence No	1
Device Event Key	53135
Manufacturer	STORZ
Manufacturer Address	91 CARPENTER HILL RD CHARLTON MA 01507 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1996-11-26