FDA.reportPublic FDA data

MAUDE MDR 8608608

MDR report key
8608608
Report number
9611102-2019-00002
Event key
0
Event type
3
Date of event
2019-04-03
Date received
2019-05-14
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#

Contact
MR. HEIKO BIEDERMAN
Address
PFORZHEIMER STREET 32 KNITTLINGEN, 75438 GM
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PIRANHA SUCTION PUMPPIRANHA SUCTION PUMPRICHARD WOLF GMBHBTA22080012208001R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-1401. O

Event Narratives#

N

Patient 1

A FULL INVESTIGATION IS CURRENTLY NOT POSSIBLE SINCE THE ACTUAL DEVICE WAS NOT RETURNED TO RICHARD WOLF (B)(4). THE INSTITUTION WAS CONTACTED FOR FURTHER INFORMATION. RICHARD WOLF (B)(4) CONSIDERS THIS CASE OPEN AND AS SOON AS ADDITIONAL INFORMATION IS AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

D

Patient 1

ON (B)(6) 2019, AN INCIDENT OCCURED DURING SURGERY AT THE (B)(6) HOSPITAL. THE DEVICE IN QUESTION IS: IRRIGATOR/ ASPIRATOR, REF: MODEL PIRANHA 2208 AND SERIAL NUMBER: (B)(4). THE PROBLEM IS: "AFTER COMPLETE ENUCLEATION OF THE PROSTATE, FRAGMENTATION WAS IMPOSSIBLE DESPITE TESTING AND REPLACING ALL DEVICES ( LEAKAGE IN THE VACUUM CIRCUIT). THE RESECTION MODE HAD TO BE CHANGED AND THE OPERATION EXTENDED BY 3H 30 MIN. A TECHNICIAN THEN INTERVENE AND THE COLLECTION CONTAINER ATTACHED TO THE VACUUM CLEANER WAS REPLACED BY A LARGER ONE. SINCE THIS INTERVENTION, THE PROBLEM HAS NOT OCCURED AGAIN."