MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-10 for PRESTIGE ATRA GRASPERSGL-ACT5MM 36CM 8360-00 manufactured by Aesculap Inc.
[182930958]
At this time, the supplier is identified as smith & nephew, based on material and lot #. Additional information / investigation results will be provided in a supplemental report, if available.
Patient Sequence No: 1, Text Type: N, H10
[182930959]
It was reported that there was an issue with a prestige grasper. When lifting the instrument off the rack, tip of grasper fell off. It was noted that the screw connecting the handle to the shaft was missing. There was no patient harm; the device was not used for a procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2020-00055 |
| MDR Report Key | 9813157 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-02-14 |
| Date Added to Maude | 2020-03-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS LINDSAY CHROMIAK |
| Manufacturer Street | 3773 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY, PA |
| Manufacturer Country | US |
| Manufacturer G1 | AESCULAP INC |
| Manufacturer Street | 3773 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY, PA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESTIGE ATRA GRASPERSGL-ACT5MM 36CM |
| Generic Name | REUSABLE INSTRUMENTS |
| Product Code | NWV |
| Date Received | 2020-03-10 |
| Model Number | 8360-00 |
| Catalog Number | 8360-00 |
| Lot Number | L4705 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP INC |
| Manufacturer Address | 3773 CORPORATE PARKWAY CENTER VALLEY, PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-10 |