MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-06 for 27050G-S manufactured by Karl Storz.
[88448238]
Patient Sequence No: 1, Text Type: N, H10
[88448240]
The doctor was using the cutting loop and the loop broke in half. The surgeon requested a new cutting loop. The patient was not injured and no pieces were in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6922229 |
| MDR Report Key | 6922229 |
| Date Received | 2017-10-06 |
| Date of Report | 2017-09-12 |
| Date of Event | 2017-09-11 |
| Report Date | 2017-09-12 |
| Date Reported to FDA | 2017-09-12 |
| Date Reported to Mfgr | 2017-09-12 |
| Date Added to Maude | 2017-10-06 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Generic Name | HYSTEROSCOPE AND ACCESSORIES |
| Product Code | NWW |
| Date Received | 2017-10-06 |
| Model Number | 27050G-S |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ |
| Manufacturer Address | 2151 E. GRAND AVENUE EL SEGUNDO CA 90245 US 90245 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-06 |