MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-02-28 for CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX UNK manufactured by Applied Medical Resources.
[137509306]
No product is being returned for evaluation and no lot # has been provided to manufacturer. A final report will be sent once the results have been analyzed.
Patient Sequence No: 1, Text Type: N, H10
[137509307]
Procedure performed: unknown. Dr. Produced an anecdotal story of a registra using cb030, getting confused with epix graspers (in which they were also using) and accidentally perforating the patients bowel. I delved further into this and apparently it happend a couple of years ago and has put dr. Off of using cb030. Incident date: unknown. Patient status: unknown. Type of intervention: unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2019-00369 |
| MDR Report Key | 8380521 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-28 |
| Date of Report | 2019-06-06 |
| Date Mfgr Received | 2019-01-24 |
| Date Added to Maude | 2019-02-28 |
| 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 | CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX |
| Generic Name | HET |
| Product Code | HET |
| Date Received | 2019-02-28 |
| Model Number | CB030 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 1. Other | 2019-02-28 |