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 2019-03-01 for PNCL,TO,STD,1"BD,10',HLS,NC,S 130321 manufactured by Consolidated Medical Equipment.
[137708284]
The alleged 130321 device is not expected to be returned for evaluation and review. A supplemental and final report will be filed following the completion of the complaint investigation. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[137708325]
The sales representative reported on behalf of the customer that the 130321, pncl,to. Std. 1"bd,10',hls,nc. S, device was being used during a liver transplant procedure on (b)(6) 2019 when the user "slid out the blade to do some coag on the tissue. When (the user) pressed the coag button (the user) got an electric arc to a nearby forceps. This melted the tip of the blade. By mistake (the user) had selected spray coag instead of standard coag. (the user) also used 50w. That? S too high. This was a mistake by the staff and this is now corrected". There was no report of fragmentation or component falling into the patient. There was no report of user or patient injury; therefore, there was also no medical intervention or hospitalization required due to this event. The event did cause a 5-minute delay in the procedure; however, the procedure was completed successfully without having to use an alternate device. This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007305485-2019-00046 |
| MDR Report Key | 8381725 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-01 |
| Date of Report | 2019-03-26 |
| Date of Event | 2019-01-31 |
| Date Mfgr Received | 2019-03-20 |
| Device Manufacturer Date | 2018-03-23 |
| Date Added to Maude | 2019-03-01 |
| 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 | MR. JOHN BERGA |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995358 |
| Manufacturer G1 | CONSOLIDATED MEDICAL EQUIPMENT |
| Manufacturer Street | ALEJANDRO DUMAS AVE, 11321 COMPLEJO INDUSTRIAL CHIHUAHUA |
| Manufacturer City | CHIHUAHUA, 31136 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 31136 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PNCL,TO,STD,1"BD,10',HLS,NC,S |
| Generic Name | APPARATUS, ELECTROSURGICAL |
| Product Code | HAM |
| Date Received | 2019-03-01 |
| Catalog Number | 130321 |
| Lot Number | 201803234 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONSOLIDATED MEDICAL EQUIPMENT |
| Manufacturer Address | ALEJANDRO DUMAS AVE, 11321 COMPLEJO INDUSTRIAL CHIHUAHUA CHIHUAHUA, 31136 MX 31136 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-01 |