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 2019-05-16 for C4140, 5MMX45CM EPIX LAPA GRASPER, 10/BX 100915402 manufactured by Applied Medical Resources.
[145641713]
Ra has just received the incident device and has been assigned to engineering for evaluation. A follow-up report will be sent upon completion of investigation.
Patient Sequence No: 1, Text Type: N, H10
[145641714]
Procedure performed: robotic repair of incarcerated hernia with mesh the surgeon was taking down the umbilical hernia and was pulling on tissue with the grasper when it bent past the jaws. The surgeon could not open the jaws still attached to the tissue so the jaws were just pulled off the tissue. When the unit was removed from the trocar the shaft broke completely. All materials were retrieved from the patient. This occurred at the beginning of the case. The robot was not docked yet. No patient injury occurred. The case was continued after removal of the unit. It is unknown if the device was replaced. A picture is available. The patient is stable. No patient demographics were available. Patient status: no injury, patient is stable. Type of intervention: the unit was removed and all pieces were retrieved from the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2019-00452 |
| MDR Report Key | 8617805 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-16 |
| Date of Report | 2019-06-25 |
| Date of Event | 2019-04-17 |
| Date Mfgr Received | 2019-04-17 |
| Device Manufacturer Date | 2019-01-08 |
| Date Added to Maude | 2019-05-16 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | WENDY KOBAYASHI |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138059 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C4140, 5MMX45CM EPIX LAPA GRASPER, 10/BX |
| Generic Name | LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC |
| Product Code | NWV |
| Date Received | 2019-05-16 |
| Returned To Mfg | 2019-05-10 |
| Model Number | C4140 |
| Catalog Number | 100915402 |
| Lot Number | 1344710 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-16 |