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 2020-01-28 for PRESTIGE ATRA GRASPER DBL-ACT 5MM 8360-10 manufactured by Aesculap Inc.
[176771863]
Manufacturing site evaluation: additional information / investigation results will be provided in a supplemental report. Investigation on-going, if available.
Patient Sequence No: 1, Text Type: N, H10
[176771864]
It was reported that there was an issue with the prestige grasper. During surgery, 2-3 pieces of the tip of the grasper broke off into the patient. At least 2 pieces were retrieved with another laparoscopic grasper. The third piece, a spacer, would be 2-3 mm and may also have fallen through the trocar; it is non-metallic plastic material. No x-rays were taken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2020-00035 |
| MDR Report Key | 9638943 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-28 |
| Date of Event | 2020-01-13 |
| Date Facility Aware | 2019-03-11 |
| Date Mfgr Received | 2020-01-13 |
| Date Added to Maude | 2020-01-28 |
| 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 18034 |
| Manufacturer Country | US |
| Manufacturer Postal | 18034 |
| Manufacturer G1 | AESCULAP INC |
| Manufacturer Street | 3773 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY PA 18034 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 18034 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESTIGE ATRA GRASPER DBL-ACT 5MM |
| Generic Name | REUSABLE INSTRUMENTS |
| Product Code | NWV |
| Date Received | 2020-01-28 |
| Model Number | 8360-10 |
| Catalog Number | 8360-10 |
| Lot Number | L795 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP INC |
| Manufacturer Address | 3773 CORPORATE PARKWAY CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-28 |