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 2020-02-26 for CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX 101419701 manufactured by Applied Medical Resources.
[181155875]
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
[181155876]
Procedure performed: laparoscopic ileoanal pouch formation. The registrar was using the scissors to cut adhesions in the abdomen. The consultant took over the procedure and noticed that the scissors were blunt compared to usual. The consultant asked for these to be changed for fresh scissors as a result. The registrar then said that they had been struggling through the case with the scissors being blunt. The freshly opened pair of epix scissors worked as usual with no problems. Intervention: change of device. Patient status: no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2020-00385 |
| MDR Report Key | 9758123 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-01-31 |
| Device Manufacturer Date | 2019-06-20 |
| Date Added to Maude | 2020-02-26 |
| 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 | LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) |
| Product Code | HET |
| Date Received | 2020-02-26 |
| Model Number | CB030 |
| Catalog Number | 101419701 |
| Lot Number | 1360822 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-02-26 |