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.
[177645137]
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
[177645138]
Procedure performed: lap chole. Cer 1 of 2 - (b)(4). Cer 2 of 2 - (b)(4). Pending further information from surgeon however time restraints mean submitting with information currently provided, scissors found to not be cutting sufficiently, surgeon commented that they appeared blunt. Scissors from a different lot number were opened and clinician had no further issues with product. Additional information received via email on december 2, 2019 from customer relations nz, [name] 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 | 2027111-2019-00662 |
| MDR Report Key | 9468446 |
| 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 |
| Returned To Mfg | 2019-12-23 |
| Model Number | CB030 |
| Catalog Number | 101419701 |
| Lot Number | 1361436 |
| 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 | 2019-12-13 |