MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-03-03 for CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX 101419701 manufactured by Applied Medical Resources.
[181931823]
Ra has just received the incident device and has been assigned to engineering for evaluation. A follow-up report will be sent upon completion of investigation.
Patient Sequence No: 1, Text Type: N, H10
[181931824]
Procedure performed: laparoscopic total hysterectomy. According to the doctor, the scissor is blunt - it didn't cut at all. He had to open another to finish the procedure. Additional information provided by product specialist via email 05feb20: the scissor was blunt from the first cut, through fat tissue. The scissor was not used to cut through staples, lap band or dense tissue. Intervention: change of device. Patient status: no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2020-00404 |
| MDR Report Key | 9783165 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-03-03 |
| Date of Report | 2020-04-03 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-02-05 |
| Device Manufacturer Date | 2019-08-15 |
| Date Added to Maude | 2020-03-03 |
| 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 | 2020-03-03 |
| Returned To Mfg | 2020-02-14 |
| Model Number | CB030 |
| Catalog Number | 101419701 |
| Lot Number | 1366452 |
| 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 | 2020-03-03 |