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 |