UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-11 for UNKNOWN manufactured by Karl Storz Endoscopy America.

Event Text Entries

[13007] After sterile preparation and draping, careful urethroscopy was performed using the 12 degree cystourethroscope. The anterior urethra appeared normal, but there was a dense stricture at the penoscrotal junction. It was passed without difficulty and opened but unfortunately, instead of opening throughout its length, the instrument remained collapsed at the distal end and opened only in the anterior urethra. The blade was withdrawn and the instrument removed and it was, at that time, that the problem with the instrument was noted. With further manipulation, the otis seemed to work satisfactorily and again it was replaced in the urethra. Unfortunately, on a second use, the instrument behaved in the same manner, failing to dilate the penoscrotal junction, but only spreading in the anterior urethra. It was elected to proceed with urethroscopy and visual internal urethrotomy using the instrument. The instrument was passed with full vision but, unfortunately, there was now a false passage at the level of the bulbar urethra adjacent to the penoscrotal stricture. The stricture was no more than 1 cm in length. The stricture was divided and, after the division of the stricture, the lumen of the bulb could not be identified. Three attempts were made using direct vision and gentle manipulation, but unfortunately the bulbar urethra could not be negotiated safely. It was elected to place a suprapubic catheter. This was done using a size 12 borge catheter that was placed in the midline in the suprapublic area. The catheter was attached to appropriate leg bag and sutured in place using 2-0 silk sutures. The patient was returned to the recovery room in satisfactory condition, with a large dressing applied to the penis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number16747
MDR Report Key16747
Date Received1994-08-11
Date of Report1994-03-31
Date of Event1993-12-06
Date Facility Aware1994-03-23
Report Date1994-03-31
Date Reported to Mfgr1994-03-31
Date Added to Maude1994-10-12
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Generic NameOTIS URETHROTOME
Product CodeEZO
Date Received1994-08-11
Model NumberUNKNOWN
Catalog NumberUNKNOWN
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age*
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key16680
ManufacturerKARL STORZ ENDOSCOPY AMERICA
Manufacturer Address10111 W. JEFFERSON BLVD. CULVER CITY CA 902323509 US


Patients

Patient NumberTreatmentOutcomeDate
10 1994-08-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.