MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-28 for COAGULATING BIPOLAR ELECTRODE 28762KB manufactured by Karl Storz Gmbh & Co. Kg Tuttlingen, Germany.
[68969162]
Evaluation confirmed that the distal end teflon is burned, melted and cracked. Also the shaft is bent, and the proximal end label is illegible. The instrument has a date code of sx(05/2012) and it has been in use for approximately 5 years. Damage is consistent with wear of long use/stress overload.
Patient Sequence No: 1, Text Type: N, H10
[68969163]
Allegedly, during a ventriculostomy procedure the doctor noted that the instrument sparked during the procedure. The instrument was immediately replaced and the procedure was completed with no delay. The hospital reported there was no serious injury to patient.
Patient Sequence No: 1, Text Type: D, B5
[71001339]
This is a supplemental. I listed the wrong part number in the mdr. I listed 28162kb; it should be 28762kb. I also added udi #. I will make correction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2017-00019 |
| MDR Report Key | 6367127 |
| Date Received | 2017-02-28 |
| Date of Report | 2017-01-30 |
| Date of Event | 2017-01-30 |
| Date Mfgr Received | 2017-01-30 |
| Device Manufacturer Date | 2012-05-01 |
| Date Added to Maude | 2017-02-28 |
| 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 TUTTLINGEN, GERMANY |
| Manufacturer Street | MITTLESTRASSE 8, 78503 |
| Manufacturer City | TUTTLINGEN, GERMANY, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COAGULATING BIPOLAR ELECTRODE |
| Generic Name | COAGULATING BIPOLAR ELECTRODE |
| Product Code | GWG |
| Date Received | 2017-02-28 |
| Returned To Mfg | 2017-02-08 |
| Model Number | 28762KB |
| Catalog Number | 28762KB |
| Lot Number | SX |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-02-28 |