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 2017-10-26 for BIPOLAR CUTTING LOOP 26040GP1 manufactured by Karl Storz Se & Co. Kg.
[91102533]
Device will not be returned for evaluation as it was disposed of by customer. It is possible that the broken piece was removed with resected tissue. The cause of breakage cannot be determined without an evaluation. Possible causes are: using too high of a setting on the esu, or mechanical manipulation of the loop when not activated.
Patient Sequence No: 1, Text Type: N, H10
[91102534]
Allegedly, the electrode loop broke off in the patient during a procedure. X-ray was done afterwards and they did not see the broken piece in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2017-00088 |
| MDR Report Key | 6981914 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-26 |
| Date of Report | 2017-09-29 |
| Date of Event | 2017-09-28 |
| Date Mfgr Received | 2017-09-29 |
| Date Added to Maude | 2017-10-26 |
| 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 902455017 |
| Manufacturer Country | US |
| Manufacturer Postal | 902455017 |
| 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 | 3 |
| Brand Name | BIPOLAR CUTTING LOOP |
| Generic Name | BIPOLAR CUTTING LOOP |
| Product Code | HIN |
| Date Received | 2017-10-26 |
| Model Number | 26040GP1 |
| Catalog Number | 26040GP1 |
| Operator | PHYSICIAN |
| 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 | MITTLESTRASSE 8, 78503 TUTTLINGEN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-26 |