FDA.reportPublic FDA data

MAUDE MDR 5186420

MDR report key
5186420
Report number
9611102-2015-00004
Event key
0
Event type
3
Date of event
2015-05-11
Date received
2015-10-29
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. OLIVER EHRLICH
Address
32 PFORZHEIMER STREET KNITTLINGEN, 75438 GM
Phone
43-43-0433
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RESECTOSCOPE SHEATHSHEATHRICHARD WOLF GMBHFDC86613741866137411211303Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-10-290

Event Narratives#

N

Patient 1

DEVICE RECENTLY RECEIVED DEVICE AND INVESTIGATION IS CURRENTLY INPROCESS. (B)(4) CONSIDERS THIS REPORT OPEN AND FOLLOW-UP REPORT TO BE SENT AT A LATER TIME.

D

Patient 1

FACILITY REPORTED THAT A DEVICE ARCHED AND DAMAGED THE TIP OF A SECOND DEVICE BEING USED DURING THE PROCEDURE. THE TWO IMPACTED DEVICES WERE SWAPPED OUT TO BACK UP DEVICES, READILY AVAILABLE FOR USE, AND PROCEDURE WAS COMPLETED AS SCHEDULED. NO INJURY TO PATIENT OR STAFF REPORTED. AT LEAST SIX DEVICES ARE ASSEMBLED TOGETHER IN ORDER TO OPERATED. THE TWO DEVICES WHICH HAD PRODUCT PROBLEMS AND THEIR ASSOCIATED MDR'S ARE: SHEATH (8661.3741) - MDR9611102-2015-00004 (TIP DAMAGED). ELECTRODE (8424.141) - MDR9611102-2015-00005 (DEVICE ARCHED).

N

Patient 1

INVESTIGATION HAS NOW BEEN COMPLETED, THIS FOLLOW-UP IS NOTIFICATION OF RESULTS. THE ACTUAL DEVICE WAS RETURNED TO (B)(4) FOR INVESTIGATION ON (B)(4) 2015. THE CERAMIC TIP OF THE SHEATH HAD PIECES BROKEN OFF FROM THE DISTAL TIP. THE DEVICE WAS SENT IN TOGETHER WITH THE ELECTRODE THAT WAS BEING USED DURING THE TIME OF THE ISSUE. DISTAL END OF THE ELECTRODE WAS MISSING APPROXIMATELY 15MM OF INSULATION MOST LIKELY THE SOURCE OF CURRENT CAUSING DAMAGE TO CERAMIC TIP OF SHEATH. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. IE INTENDED USE, INDICATIONS AND FIELD OF USE, PREPARATION AND CAUTIONS REGARDING HIGH TEMPERATURES AND USE OF IRRIGATION FLUID. (B)(4) CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT (B)(4) RECEIVES ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE PROVIDED TO FDA.

D

Patient 1

THIS IS A FOLLOW-UP #1