MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-07-14 for BIPOLAR CUTTING LOOP 26040GP1 manufactured by Karl Storz Gmbh & Co. Kg Tuttlingen, Germany.
[80060442]
The electrode has not been returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[80060443]
Allegedly, during a myomectomy procedure the doctor noted that the loop broke and fell into the patient. He did an x-ray and the results were negative. They searched through suctioned fluid and found it there. The hospital reported there was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2017-00055 |
| MDR Report Key | 6714374 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-07-14 |
| Date of Report | 2017-06-15 |
| Date of Event | 2017-06-15 |
| Date Mfgr Received | 2017-06-15 |
| Date Added to Maude | 2017-07-14 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. SUSIE CHEN |
| Manufacturer Street | 2151 E. GRAND AVENUE |
| Manufacturer City | EL SEGUNDO CA 902455017 |
| Manufacturer Country | US |
| Manufacturer Postal | 902455017 |
| Manufacturer Phone | 4242188519 |
| Manufacturer G1 | KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY |
| Manufacturer Street | MITTLESTRASSE 8, 78503 |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIPOLAR CUTTING LOOP |
| Generic Name | BIPOLAR CUTTING LOOP |
| Product Code | HIN |
| Date Received | 2017-07-14 |
| Model Number | 26040GP1 |
| Catalog Number | 26040GP1 |
| Lot Number | 53497 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY |
| Manufacturer Address | MITTLESTRASSE 8, 78503 TUTTLINGEN, GERMANY, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-14 |