MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-01-27 for PRESTIGE ATRA GRASPER DBL-ACT 5MM 8360-10 manufactured by Aesculap Inc.
[176572342]
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report, if applicable or available.
Patient Sequence No: 1, Text Type: N, H10
[176572343]
It was reported that there was an issue with the prestige grasper. During a laparoscopic procedure, the tip fell apart into pieces. This was noted upon insertion; it was unknown if the instrument had broken prior, during, or after introduction into the trocar. The pieces were recovered and x-ray results confirmed removal. There was a short delay due to the x-ray.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2020-00028 |
| MDR Report Key | 9633624 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-01-27 |
| Date of Report | 2020-01-27 |
| Date of Event | 2020-01-10 |
| Date Mfgr Received | 2020-01-10 |
| Date Added to Maude | 2020-01-27 |
| 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 | 2020-01-27 |
| Model Number | 8360-10 |
| Catalog Number | 8360-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-01-27 |