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 2020-03-12 for PRESTIGE ATRA GRASPER DBL-ACT 5MM 8360-10 manufactured by Aesculap Inc.
[183257935]
The device, manufactured by smith & nephew, was forwarded to the supplier for investigation. Upon review of the evaluation, the failure of the device was clarified; the complaint was re-assessed due to receipt of this additional information. Investigation results: one 8360-10 was returned. This is a 6-year old reusable instrument. The complaint allegation stated: the handle is fetching (separated) from the shaft. Visual inspection confirmed broken jaw assembly. The bottom jaw paddle component was absent from the return. The jaw mechanism appears to have been forced. The scissor action functions but the linear button is no longer seated properly. The button maintains and allows the spring-loaded scissor loop action. The symptoms align with rotational difficulty. It is undetermined whether the rotator did not perform as intended or the front end was forced with no rotational difficulty first. Per instructions for use (ifu): "prestige endoscopic graspers are designed to grasp soft tissue structures during endoscopic procedures. Aesculap endoscopic graspers are designed to be used through a cannula, or port, commonly called a trocar sleeve. Any use of an instrument for a task other than its intended purpose will usually result in a damaged or broken instrument. Lateral pressure on the instrument when inserting or removing it may damage the shaft or the working tip". The product met specifications upon release to distribution.
Patient Sequence No: 1, Text Type: N, H10
[183257936]
It was reported that there was an issue with the prestige grasper. After a case, it was noticed that the handle was "fetching" from the shaft. There was no known patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2020-00052 |
| MDR Report Key | 9826191 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2019-05-27 |
| Date Mfgr Received | 2019-10-03 |
| Date Added to Maude | 2020-03-12 |
| 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 | 2020-03-12 |
| Returned To Mfg | 2019-06-06 |
| Model Number | 8360-10 |
| Catalog Number | 8360-10 |
| Lot Number | L50460282 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-12 |