MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-17 for BIPOLAR CUTTING LOOP 26040GP1 manufactured by Karl Storz Se & Co. Kg.
[133485186]
The electrode has not been returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[133485187]
Allegedly, during a hysteroscopic myomectomy procedure, the bipolar electrode loop broke and the doctor requested the myosure tissue removal system and subsequently found a small piece of loop from the electrode inside the myosure tissue removal system. They confirmed all pieces had been removed and there was no patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2019-00012 |
| MDR Report Key | 8259001 |
| Date Received | 2019-01-17 |
| Date of Report | 2019-01-16 |
| Date of Event | 2018-11-14 |
| Date Added to Maude | 2019-01-17 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. SUSIE CHEN |
| Manufacturer Street | 2151 EAST GRAND AVENUE |
| Manufacturer City | EL SEGUNDO CA 902455017 |
| Manufacturer Country | US |
| Manufacturer Postal | 902455017 |
| Manufacturer G1 | KARL STORZ SE & CO. KG |
| Manufacturer Street | DR.-KARL-STORZ-STRASSE 34 78532 |
| Manufacturer City | TUTTLINGEN, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BIPOLAR CUTTING LOOP |
| Generic Name | BIPOLAR CUTTING LOOP |
| Product Code | HIN |
| Date Received | 2019-01-17 |
| Model Number | 26040GP1 |
| Catalog Number | 26040GP1 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ SE & CO. KG |
| Manufacturer Address | DR.-KARL-STORZ-STRASSE 34 78532 TUTTLINGEN, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-17 |