MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2019-05-30 for C4120, 38CM GRASPER REPOS CART, 10/BX 101472471 manufactured by Applied Medical Resources.
[146517975]
The incident device is anticipated to return. A follow-up report will be provided upon completion of investigation.
Patient Sequence No: 1, Text Type: N, H10
[146517976]
Procedure performed: unk. Medwatch # (b)(4). The grasper jaws were tight, did not open and close properly. They were taken off the field and replaced with new device without event. There was no harm to the patient. Date of event: (b)(6) 2019. Additional information received via email on 06may2019 from risk management coordinator: date of event (b)(6) 2019 same as stated on medwatch report. Information not provided for the questions at what point during the procedure did the device become difficult to actuate. Information not provided for the question was it difficult to actuate upon initial use. Patient status: there was no harm to the patient. Type of intervention: they were taken off the field and replaced with new device without event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2019-00458 |
| MDR Report Key | 8654483 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2019-05-30 |
| Date of Report | 2019-06-27 |
| Date of Event | 2019-02-11 |
| Date Mfgr Received | 2019-04-30 |
| Device Manufacturer Date | 2018-12-07 |
| Date Added to Maude | 2019-05-30 |
| 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 | C4120, 38CM GRASPER REPOS CART, 10/BX |
| Generic Name | NWV |
| Product Code | NWV |
| Date Received | 2019-05-30 |
| Model Number | C4120 |
| Catalog Number | 101472471 |
| Lot Number | 1343486 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-05-30 |