MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-04-03 for TUBE, INNER ROTATABLE CERAMIC 27050XA manufactured by Karl Storz Gmbh & Co. Kg Tuttlingen, Germany.
[71579393]
The ceramic beak of the sheath shows char from arcing and a small piece is missing from the ceramic beak. It is possible the electrode was fired when inside the sheath causing damage to the ceramic beak and to the electrode. We cannot confirm. We filed mdr (mfg #: 9610617-2017-00026) on the electrode.
Patient Sequence No: 1, Text Type: N, H10
[71579394]
Allegedly, during a procedure, arcing occurred and damaged the ceramic beak and a piece may have fallen into the patient or it may have been removed with the resected tissue. The hospital reported that there was no injury to the patient. The hospital did not respond to medical event questions so we cannot confirm the whereabouts of the piece and whether it was retrieved or left inside the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2017-00025 |
| MDR Report Key | 6455517 |
| Report Source | USER FACILITY |
| Date Received | 2017-04-03 |
| Date of Report | 2017-03-03 |
| Date of Event | 2017-03-03 |
| Date Mfgr Received | 2017-03-03 |
| Device Manufacturer Date | 2015-04-01 |
| Date Added to Maude | 2017-04-03 |
| 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 | 4242188519 |
| 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 | TUBE, INNER ROTATABLE CERAMIC |
| Generic Name | INNER TUBE |
| Product Code | FBO |
| Date Received | 2017-04-03 |
| Returned To Mfg | 2017-03-13 |
| Model Number | 27050XA |
| Catalog Number | 27050XA |
| Lot Number | RU |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 2017-04-03 |