MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-02-08 for CONDELA N/A 8075-26-0210 manufactured by Condela.
[1443]
11/24/92 patient diagnosed with calculus of ureter. Lithotripsy with condela laser used. No apparent problems noted. 1/4/93 patient admitted with cardiac compensation. 1/5/93 surgery performed for removal of laser fibers enbedded in diaphram and right ventricle. 1/10/93 discharged home in satisfactory conditiondevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-nov-92. Service provided by: other. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: yes. Corrective actions: device discarded. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2535 |
| MDR Report Key | 2535 |
| Date Received | 1993-02-08 |
| Date of Report | 1993-01-22 |
| Date of Event | 1993-01-05 |
| Date Facility Aware | 1993-01-05 |
| Report Date | 1993-01-22 |
| Date Reported to FDA | 1993-01-22 |
| Date Reported to Mfgr | 1993-01-06 |
| Date Added to Maude | 1993-03-11 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONDELA |
| Generic Name | FIBER OPTIC |
| Product Code | GDB |
| Date Received | 1993-02-08 |
| Model Number | N/A |
| Catalog Number | 8075-26-0210 |
| Lot Number | PBJ017925 |
| ID Number | 200 MICRON FIBER |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 2358 |
| Manufacturer | CONDELA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-02-08 |