MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-09-28 for CORE TRUMPET 5X32CM 1 OR 2 BAG CD8190 manufactured by Consolidated Medical Equipment.
[87651294]
The device was not returned by the user facility therefore is unable to be evaluated. A review of manufacturing documents was not possible as the lot number for this product was not made available. A historical review of complaint data revealed one complaint in the past two years. In the same timeframe (b)(4) units have been sold worldwide, making the rate of occurrence of this failure (b)(4) percent. The severity of this issue will need to be re-evaluated. This complaint has been escalated to determine if further investigation is required. If relevant information is gathered regarding this incident, the record will be re-opened and a follow-up report will be filed. The reported failure will continue to be tracked and trended through the complaint system.
Patient Sequence No: 1, Text Type: N, H10
[87651295]
During a laparoscopic splenectomy, the surgeon reported having issues with the suction button of the core suction irrigation. The suction button of the handpiece kept becoming depressed during the case, resulting in inferior suction. When a vessel was cut during the procedure bleeding occurred and, due to inferior suction of the reported device, visibility was compromised. To control the bleeding, the procedure was converted from laparoscopic to an open procedure. To date, no patient status information has been provided. This report is raised on the basis of a reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007305485-2017-00198 |
| MDR Report Key | 6901168 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-09-28 |
| Date of Report | 2017-09-28 |
| Date of Event | 2017-08-31 |
| Date Mfgr Received | 2017-09-01 |
| Date Added to Maude | 2017-09-28 |
| 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 | MRS. MARTH CAMACHO URRIBARRI |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 135025994 |
| Manufacturer Country | US |
| Manufacturer Postal | 135025994 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 135025994 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 135025994 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORE TRUMPET 5X32CM 1 OR 2 BAG |
| Generic Name | CORE SUCTION/IRRIGATION |
| Product Code | GBW |
| Date Received | 2017-09-28 |
| Catalog Number | CD8190 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONSOLIDATED MEDICAL EQUIPMENT |
| Manufacturer Address | AVE. ALEJANDRO DUMAS NO. 11321 COMPLEJO INDUSTRIAL CHIHUAHUA CHIHUAHUA, CHIHUAHUA CP 31136 MX CP 31136 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-28 |