MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-01 for JARIT INSULATED LAPAROSCOPIC SPATULA 600-317 manufactured by Integra Lifesciences Corp..
[122803258]
A spark occurred in surgery. No patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080279 |
| MDR Report Key | 7926352 |
| Date Received | 2018-10-01 |
| Date Added to Maude | 2018-10-02 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | JARIT INSULATED LAPAROSCOPIC SPATULA |
| Generic Name | SPATULA, SURGICAL, GENERAL AND PLASTIC SURGERY |
| Product Code | GAF |
| Date Received | 2018-10-01 |
| Catalog Number | 600-317 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORP. |
| Manufacturer Address | 311 ENTERPRISE DR PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-01 |