MAUDE MDR 16747

MDR report key
16747
Report number
16747
Event key
0
Event type
3
Date of event
1993-12-06
Date received
1994-08-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OTIS URETHROTOMEKARL STORZ ENDOSCOPY AMERICAEZOUNKNOWNUNKNOWNUNKNOWNNN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11994-08-110

Event Narratives#

D

Patient 1

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 THE BLADE WAS WITHDRAWN AND THE INSTRUMENT REMOVED AND IT WAS, AT THAT TIME, THAT THE PROBLEM WITH THE INSTRUMENT WAS NOTED.WITH FURTHER MANIPULATION, THE OTIS SEEMED TO WORK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.