FDA.reportPublic FDA data

MAUDE MDR 6198752

MDR report key
6198752
Report number
9611102-2016-00018
Event key
0
Event type
3
Date received
2016-12-22
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
1DISCOSCOPE, 25 DEGREE, 6.9MM SL, 207MMENDOSCOPERICHARD WOLF GERMANY (GMBH)GCM89210125489210.1254Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-12-2201. O

Event Narratives#

N

Patient 1

ACTUAL DEVICE RETURNED TO MANUFACTURER ON 12/13/2016. INVESTIGATION/EVALUATION CURRENTLY IN PROCESS. (B)(4) CONSIDERS THIS REPORT OPEN, FOLLOW-UP REPORT TO BE SUBMITTED ONCE INVESTIGATION IS COMPLETE. (B)(4). EVALUATION OF DEVICE INPROCESS.

D

Patient 1

RICHARD WOLF (B)(4) WAS NOTIFIED SURGERY WAS STOPPED WHILE USING DEVICE IN QUESTION. THE REASON FOR STOPPING PROCEDURE IS UNKNOWN AT THIS TIME. FACILITY HAS BEEN CONTACT REQUESTING ADDITIONAL INFORMATION REGARDING THE EVENT, NO RESPONSE AS OF 12/22/2016.