MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-11-19 for BIPOLAR ELECTRODES 26040GP1 manufactured by Karl Storz Gmbh & Co..
[15821265]
Allegedly, the doctor was performing a small fibroid removal, but discovered during the case a very large, vascular myoma that had grown into the uterine wall. The doctor experienced difficulties in addressing this condition resulting in excessive bleeding, extended procedure time, a perforated uterus and hospitalization. During the procedure, the electrode arced and broke and the loop fell into the pt. The doctor retrieved the piece. The broken electrode did not cause the bleeding, extended procedure time, perforated uterus or hospitalization.
Patient Sequence No: 1, Text Type: D, B5
[16216107]
It is possible that too much stress was applied to the electrode during use resulting in arcing and detachment of the loop.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610617-2014-00059 |
| MDR Report Key | 4298218 |
| Report Source | 06 |
| Date Received | 2014-11-19 |
| Date of Report | 2014-10-17 |
| Date of Event | 2014-10-16 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2014-12-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUSIE |
| Manufacturer Street | 2151 E GRAND AVE |
| Manufacturer City | EL SEGUNDO CA 902455017 |
| Manufacturer Country | US |
| Manufacturer Postal | 902455017 |
| Manufacturer Phone | 4242188201 |
| Manufacturer G1 | KARL STORZ GMBH & CO. KG |
| Manufacturer Street | MITTELSTRASSE 8 |
| Manufacturer City | TUTTLINGEN |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIPOLAR ELECTRODES |
| Generic Name | BIPOLAR CUTTING LOOP |
| Product Code | HIN |
| Date Received | 2014-11-19 |
| Returned To Mfg | 2014-11-13 |
| Model Number | 26040GP1 |
| Catalog Number | 26040GP1 |
| Lot Number | 48403 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-11-19 |