MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-29 for CODMAN UNKNOWN 24-3087 manufactured by Codman & Shurteff.
[6895]
During surgery the patient received first and second degree burns on the upper abdomen associated with a laparscopic light cord wihich was apparently coupling between the fiber-optic cord and the laparoscope was defective, no information is available regarding related devices. 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. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: mechanical problem. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: yes. Corrective actions: device repaired and put back in service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9059 |
| MDR Report Key | 9059 |
| Date Received | 1994-07-29 |
| Date of Report | 1994-03-04 |
| Date of Event | 1994-01-28 |
| Date Facility Aware | 1994-01-28 |
| Report Date | 1994-03-04 |
| Date Reported to Mfgr | 1994-03-04 |
| Date Added to Maude | 1994-11-18 |
| 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 | CODMAN |
| Generic Name | FIBER-OPTIC LIGHT CORD |
| Product Code | GDB |
| Date Received | 1994-07-29 |
| Model Number | UNKNOWN |
| Catalog Number | 24-3087 |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 8719 |
| Manufacturer | CODMAN & SHURTEFF |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-07-29 |