MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-07 for COLD KNIFE 27069K manufactured by Karl Storz Se & Co. Kg.
[101975395]
The device has not yet been received and evaluated.
Patient Sequence No: 1, Text Type: N, H10
[101975396]
Allegedly, the during an optical uretherotomy procedure, the cold knife broke off in the patient's urethra. ; the broken piece was not able to be retrieved. The surgeon plans on retrieving the piece during the patient's next surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2018-00014 |
| MDR Report Key | 7322436 |
| Date Received | 2018-03-07 |
| Date of Report | 2018-02-09 |
| Date of Event | 2018-02-07 |
| Date Mfgr Received | 2018-02-07 |
| Date Added to Maude | 2018-03-07 |
| 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 | 2151 E. GRAND AVENUE |
| Manufacturer City | EL SEGUNDO CA 902455017 |
| Manufacturer Country | US |
| Manufacturer Postal | 902455017 |
| Manufacturer Phone | 4242188201 |
| Manufacturer G1 | KARL STORZ SE & CO. KG |
| Manufacturer Street | DR.-KARL-STORZ-STRASSE 34 78532 |
| Manufacturer City | TUTTLINGEN, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COLD KNIFE |
| Generic Name | COLD KNIFE |
| Product Code | EZO |
| Date Received | 2018-03-07 |
| Model Number | 27069K |
| Catalog Number | 27069K |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-03-07 |