MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-09 for CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX 101419701 manufactured by Applied Medical Resources.
[145114500]
The incident device is anticipated to return. A follow-up report will be provided upon completion of investigation. This event is not reportable as it is unlikely to cause or contribute to death or serious injury. This report is in response to medwatch (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[145114501]
Procedure performed: lap repair of incarcerated l lumbar hernia. A plastic piece broke off the handle of the scissor during surgery. The device was replaced and the case was completed. No patient injury occurred. The device is available for return. It was unknown what was occurring at the time that the unit broke. Limited information was available. Medwatch (b)(4) received via mail on tuesday, 30apr2019: "plastic piece broke off the handle of the laparoscopic scissors during a left lumbar hernia procedure. " patient status: no patient injury occurred. Type of intervention: the device was replaced and the case was completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2019-00447 |
| MDR Report Key | 8596078 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-09 |
| Date of Report | 2019-06-06 |
| Date of Event | 2019-04-07 |
| Date Mfgr Received | 2019-04-30 |
| Device Manufacturer Date | 2018-12-31 |
| Date Added to Maude | 2019-05-09 |
| 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 | 2019-05-09 |
| Returned To Mfg | 2019-05-21 |
| Model Number | CB030 |
| Catalog Number | 101419701 |
| Lot Number | 1345805 |
| 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 | 2019-05-09 |