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 2020-03-23 for CTS22, 12X100 KII SLEEVE ZTHR 12/BX 101244801 manufactured by Applied Medical Resources.
[184498668]
The event device is anticipated to be returned to applied medical for evaluation. A follow-up report will be provided upon completion of investigation.
Patient Sequence No: 1, Text Type: N, H10
[184498669]
Procedure performed: laparoscopic pleurodesis. Event description: rep was not present for the case. The surgeon is a newly practicing surgeon. The surgeon placed the trocar between the rib cage and diaphragm. While looking around with the scope he noticed a broken fragment from the tip of the cannula. The case was converted to a open procedure to retrieve the plastic piece in the patient. The patient status is fine. The trocar is available to be returned. Intervention: converted to open to retrieve the plastic piece of the trocar. Patient status: patient is fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2020-00433 |
| MDR Report Key | 9866461 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-03-18 |
| Date Mfgr Received | 2020-03-18 |
| Device Manufacturer Date | 2019-11-14 |
| Date Added to Maude | 2020-03-23 |
| 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 | CTS22, 12X100 KII SLEEVE ZTHR 12/BX |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY |
| Product Code | GCJ |
| Date Received | 2020-03-23 |
| Model Number | CTS22 |
| Catalog Number | 101244801 |
| Lot Number | 1374795 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-23 |