MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-17 for PRESTIGE ATRA GRASPER DBL-ACT 5MM 8360-10 manufactured by Aesculap Inc.
[179725801]
When additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[179725802]
It was reported that there was an issue with a prestige grasper. The reporter indicated that the prestige was stuck in open position when it was pulled it for surgery. Per the reporter, the device malfunction was noted in the operating room but prior to the start of the procedure. As the device malfunction was noted prior to use on the patient, the device was pulled and a back up prestige grasper was used to successfully complete the surgery. This incident did not cause or contribute to serious injury or death or a delay in surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2020-00047 |
| MDR Report Key | 9717984 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-17 |
| Date of Report | 2020-02-17 |
| Date of Event | 2020-01-17 |
| Date Mfgr Received | 2020-01-17 |
| Date Added to Maude | 2020-02-17 |
| 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 Phone | 2581946507 |
| Manufacturer G1 | MICRO STAMPING CORPORATION |
| Manufacturer Street | 340 BELMONT AVENUE |
| Manufacturer City | SOMERSET, NJ |
| 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 | LAPAROSCOPIC SURGERY |
| Product Code | NWV |
| Date Received | 2020-02-17 |
| Returned To Mfg | 2020-02-03 |
| Model Number | 8360-10 |
| Catalog Number | 8360-10 |
| Lot Number | M45041 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-17 |