MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-09-30 for KARL STORZ 27040GPV NA manufactured by Karl Storz Gmbh & Co..
[20855736]
Allegedly, the doctor was performing a bipolar prostrate resection, procedure and when the electrode was activated, the patient experienced obturator nerve reaction and body jumped; this resulted in perforation of the bladder. Original procedure was completed and a catheter placed in patient to address perforation. Later, catheter was removed and patient condition is good at this time; perforation healed. There was no malfunction of karl storz instruments reported; it was determined that covidien force triad esu malfunctioned and produced too much energy which caused nerve stimulation. We filed 2 mdrs for 2 events. Reference mfr report number: 9610617-2013-00036.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3010202439-2013-00036 |
MDR Report Key | 3447165 |
Report Source | 99 |
Date Received | 2013-09-30 |
Date of Report | 2013-09-27 |
Date of Event | 2013-08-23 |
Date Facility Aware | 2013-08-29 |
Report Date | 2013-09-27 |
Date Reported to FDA | 2013-09-27 |
Date Reported to Mfgr | 2013-09-27 |
Date Added to Maude | 2013-11-05 |
Event Key | 0 |
Report Source Code | Distributor report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Street | 2151 E. GRAND AVENUE |
Manufacturer City | EL SEGUNDO CA 902450000 |
Manufacturer Country | US |
Manufacturer Postal | 902450000 |
Manufacturer G1 | KARL STORZ ENDOSCOPYAMERICA INC. |
Manufacturer Street | 2151 E. GRAND AVENUE |
Manufacturer City | EL SEGUNDO CA 90245000 |
Manufacturer Country | US |
Manufacturer Postal Code | 90245 0000 |
Single Use | 0 |
Previous Use Code | 0 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | KARL STORZ |
Generic Name | BIPOLAR ELECTRODE |
Product Code | HIN |
Date Received | 2013-09-30 |
Model Number | 27040GPV |
Catalog Number | NA |
Lot Number | UNK |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | NA |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | KARL STORZ GMBH & CO. |
Manufacturer Address | TUTTLINGEN GM |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2013-09-30 |