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 2019-12-13 for CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX 101419701 manufactured by Applied Medical Resources.
[170792451]
No product is being returned for evaluation but lot # is provided. A device history report is to be reviewed by engineering. A final report will be sent once the results have been analyzed.
Patient Sequence No: 1, Text Type: N, H10
[170792452]
Procedure performed: lap chole. Cer 1 of 2 - (b)(4). Cer 2 of 2 - (b)(4). Relating to cer (b)(4), a second pair of scissors were opened and found to also be blunt. These scissors came from the same lot number as those in cer (b)(4). Additional information received via email on december 2, 2019 from customer relations (b)(6). The two event samples have not been returned. Patient status: patient is fine, and completely unaffected intervention: product was replaced with another.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2019-00663 |
| MDR Report Key | 9468453 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-13 |
| Date of Report | 2020-03-06 |
| Date of Event | 2019-11-19 |
| Date Mfgr Received | 2019-11-25 |
| Date Added to Maude | 2019-12-13 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX |
| Generic Name | LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) |
| Product Code | HET |
| Date Received | 2019-12-13 |
| Model Number | CB030 |
| Catalog Number | 101419701 |
| Lot Number | 1361436 |
| 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 | 2019-12-13 |