MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-06-14 for MARYLAND DISSECTOR 5860000 * manufactured by Davol.
[2071742]
Physician preparing to perform laparoscopic lysis of adhesions. The physician picked up the davol maryland dissector, and the plastic piece used to tighten the instrument, fell into 3 pieces when lightly turned by him. The instrument was not used on the patient as incident happened on the surgical field, but not in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2139626 |
| MDR Report Key | 2139626 |
| Date Received | 2011-06-14 |
| Date of Report | 2011-06-14 |
| Date of Event | 2011-06-13 |
| Report Date | 2011-06-14 |
| Date Reported to FDA | 2011-06-14 |
| Date Added to Maude | 2011-06-24 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MARYLAND DISSECTOR |
| Generic Name | MARYLAND DISSECTOR (LAPAROSCOPIC INSTRUMENT) |
| Product Code | GDI |
| Date Received | 2011-06-14 |
| Model Number | 5860000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAVOL |
| Manufacturer Address | 730 CENTRAL AVE. MURRAY HILL NJ 07974 US 07974 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-14 |