MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-02-19 for A1602, 6MM L/L STEALTH CLIP 1/4 F 10/BX 101374001 manufactured by Applied Medical Resources.
[180125404]
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
[180125405]
Procedure performed: ni. The clip remained blocked in the open position when the surgeon wanted to clamp the mammary artery. Clinical consequence: none. This incident took place at the ctcv block on (b)(6) 2020 and on (b)(6) 2020. Original : le clip est rest? Bloqu? En position ouverte lorsque le chirurgien a voulu clamper l'art? Re mammaire. Cons? Quence clinique : aucune. Cet incident a eu lieu au bloc ctcv le (b)(6) 2020 et le (b)(6) 2020. Intervention: ni. Patient status: clinical consequence: none.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2020-00370 |
| MDR Report Key | 9730048 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-02-19 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-01-24 |
| Device Manufacturer Date | 2019-07-05 |
| Date Added to Maude | 2020-02-19 |
| 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 | NI |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | A1602, 6MM L/L STEALTH CLIP 1/4 F 10/BX |
| Generic Name | CLIP, VASCULAR |
| Product Code | DSS |
| Date Received | 2020-02-19 |
| Model Number | A1602 |
| Catalog Number | 101374001 |
| Lot Number | 1360356 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-02-19 |