MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-07 for BIPOLAR CUTTING LOOP ELECTRODE 26040GP1 manufactured by Karl Storz Se & Co. Kg.
[94818825]
The device was recently returned but has not yet been evaluated. A supplemental report will be submitted once the evaluation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[94818826]
Allegedly, during a hysteroscopic myomectomy procedure, a piece of the electrode cutting loop broke off inside the patient. The broken piece was retrieved and procedure was completed with no impact on patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2017-00096 |
| MDR Report Key | 7097899 |
| Date Received | 2017-12-07 |
| Date of Report | 2017-11-08 |
| Date of Event | 2017-11-08 |
| Date Mfgr Received | 2017-11-08 |
| Device Manufacturer Date | 2014-05-01 |
| Date Added to Maude | 2017-12-07 |
| 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 | DR.-KARL-STORZ-STRASSE 34 78532 |
| Manufacturer City | TUTTLINGEN, CA |
| Manufacturer Country | GM |
| Manufacturer Phone | 4242188201 |
| Manufacturer G1 | KARL STORZ GMBH & CO, KG |
| Manufacturer Street | MITTLESTRASSE 8 78503 |
| 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 ELECTRODE |
| Generic Name | BIPOLAR ELECTRODE |
| Product Code | HIN |
| Date Received | 2017-12-07 |
| Returned To Mfg | 2017-12-07 |
| Model Number | 26040GP1 |
| Catalog Number | 26040GP1 |
| Lot Number | NV04 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-12-07 |