MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-31 for 5820 32-5820 manufactured by Snowden - S Pencer.
[4240]
The scissors were used during a cabg procedure and a 1" portion of the serrated edge broke off scissors and fell into the surgical field. It was retrieved and there was no apparent harm to the patient. There was a previous situation involving these scissors during a cabg procedure when the entire serrated edge cracked. They were picked up by the sales rep. On 8/12/93. Device not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. 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: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6452 |
| MDR Report Key | 6452 |
| Date Received | 1993-08-31 |
| Date of Report | 1993-08-24 |
| Date of Event | 1993-08-17 |
| Date Facility Aware | 1993-08-17 |
| Report Date | 1993-08-24 |
| Date Reported to FDA | 1993-08-24 |
| Date Reported to Mfgr | 1993-08-24 |
| Date Added to Maude | 1993-09-15 |
| 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 |
| Generic Name | MAYO SCISSORS DIAMOND SERRATED EDGES |
| Product Code | HRR |
| Date Received | 1993-08-31 |
| Model Number | 5820 |
| Catalog Number | 32-5820 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | 01-AUG-93 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 6141 |
| Manufacturer | SNOWDEN - S PENCER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-08-31 |