MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-10 for RESECTOSCOPE INNER SHEATH 28FR 27040XB manufactured by Karl Storz Se And Co. Kg.
[145108634]
Plastic tip broke off during surgery - retrieved by surgeon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086564 |
| MDR Report Key | 8604286 |
| Date Received | 2019-05-10 |
| Date of Report | 2019-05-02 |
| Date of Event | 2019-05-01 |
| Date Added to Maude | 2019-05-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RESECTOSCOPE INNER SHEATH 28FR |
| Generic Name | RESECTOSCOPE |
| Product Code | FJL |
| Date Received | 2019-05-10 |
| Model Number | 27040XB |
| Lot Number | PS03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ SE AND CO. KG |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-10 |