MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-31 for ATRAUMATIC GRASPER M49435 manufactured by Aesculap, Inc..
[185708912]
Surgeon unable to close jaws of davis and geck grasper. Gasper then broke inside patient. 8mm trocar was placed and two small pieces were retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9902616 |
| MDR Report Key | 9902616 |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-07 |
| Report Date | 2020-03-12 |
| Date Reported to FDA | 2020-03-12 |
| Date Reported to Mfgr | 2020-03-31 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATRAUMATIC GRASPER |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY |
| Product Code | GCJ |
| Date Received | 2020-03-31 |
| Model Number | M49435 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP, INC. |
| Manufacturer Address | 3773 CORPORATE PKWY CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |