MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-15 for CUTTING LOOP, BIPOLAR, 24/26 FR 27040GP1-S manufactured by Karl Storz Se & Co. Kg.
[188078521]
"the single use electrode 27040gp-1 was found missing one side of insulation material as well as the loop wire. " according to the customer, the electrode broke off after resecting for 45 minutes. This type of occurrence most likely is due to stress and overload.
Patient Sequence No: 1, Text Type: N, H10
[188078522]
Allegedly per the customer, during a turp, the electrode broke off inside the patient. The broken part of the electrode was safely removed with no harm to the patient. The electrode was replaced and the procedure completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2020-00002 |
| MDR Report Key | 9592467 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-08 |
| Date of Event | 2019-11-26 |
| Date Mfgr Received | 2019-12-17 |
| Device Manufacturer Date | 2019-06-01 |
| Date Added to Maude | 2020-01-15 |
| 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 E. GRAND AVENUE |
| Manufacturer City | EL SEGUNDO CA 90245 |
| Manufacturer Country | US |
| Manufacturer Postal | 90245 |
| Manufacturer Phone | 4242188201 |
| Manufacturer G1 | KARL STORZ SE & CO.KG |
| Manufacturer Street | DR.-KARL-STORZ -STRASSE 34 78532 |
| Manufacturer City | TUTTLINGEN, GM, |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUTTING LOOP, BIPOLAR, 24/26 FR |
| Generic Name | BIPOLAR SINGLE USE CUTTING LOOP |
| Product Code | FAS |
| Date Received | 2020-01-15 |
| Model Number | 27040GP1-S |
| Catalog Number | 27040GP1-S |
| Lot Number | TQ |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 1. Required No Informationntervention | 2020-01-15 |