MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-17 for PRESTIGE ATRA GRASPER DBL-ACT 5MM 8360-10 manufactured by Aesculap Inc.
[183893580]
Supplier reported as smith & nephew. Additional information / investigation results will be provided in a supplemental report, if received.
Patient Sequence No: 1, Text Type: N, H10
[183893581]
It was reported that there was an issue with a prestige grasper, received via information from medwatch form (b)(4). During a xi robotic assisted laparoscopic uterine myomectomy, there was a malfunction. A davinci scissor tip slipped off the monopolar scissors. The surgeon went to retrieve the tip with a grasper. In the first attempt, the scissor tip was not retrieved, so the grasper was put through the trocar again. The tip of the grasper broke during the second attempt and there was possibly a small fragment (<5mm) that was not recovered and remained in the patient. It was noted that there have been previous issues with the scissor tips coming off during use. Additional information was not provided. Involved components: computer controlled surgical instrument; 400180; intuitive surgical inc, davinci system; is4000, 763379: intuitive surgical inc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2020-00072 |
| MDR Report Key | 9842403 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-17 |
| 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 GRASPER DBL-ACT 5MM |
| Generic Name | REUSABLE INSTRUMENTS |
| Product Code | NWV |
| Date Received | 2020-03-17 |
| Model Number | 8360-10 |
| Catalog Number | 8360-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2020-03-17 |