MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-11-19 for PKS BILL BL0533 manufactured by Gyrus Medical Ltd..
[4165173]
Gyrusacmi was notified that the surgeon was using the device for a last procedure, the patient had fibroids which may have complicated the matter making it difficult to position the loop. When the loop was in position and the surgeon was trying to pull the loop closed while activating, but it was not cutting. Due to a significant amount of blood, the procedure was converted to an open case. The bleeding was present prior to the device being used, so this is not the likely cause. It was suggested to remove some of the blood which may have been acting as a short circuit so the energy was not delivered to the tissue.
Patient Sequence No: 1, Text Type: D, B5
[11438843]
No product was returned for investigation. Additional information provided by the technical authority for the pks bill. The device was used without sufficient visualization around the cutting plane prior to activation against the instructed in the ifu. The tissue diameter cut was greater than 30mm which is warned against in the ifu. Excessive force was used during activation which is warned against in the ifu. The excessive force combined with a large diameter of tissue pulled the electrodes apart and inhibited activation. The conclusion was surgeon misuse. The surgeon has since used the device successfully and commented on how quick and effective the cutting performance was. A follow up visit is planned in december to view a case and support our colleagues. The conclusion from the investigation was surgeon misuse.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617070-2013-00020 |
| MDR Report Key | 3581593 |
| Report Source | 06,07 |
| Date Received | 2013-11-19 |
| Date of Report | 2013-10-22 |
| Date of Event | 2013-10-07 |
| Date Mfgr Received | 2013-10-24 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2014-02-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE RD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5088042739 |
| Manufacturer G1 | GYRUS MEDICAL LTD. |
| Manufacturer Street | FORTRAN RD., ST. MELLONS |
| Manufacturer City | CARDIFF CF3OLT |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CF3 OLT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PKS BILL |
| Generic Name | PKS BILL |
| Product Code | HIN |
| Date Received | 2013-11-19 |
| Model Number | BL0533 |
| Catalog Number | BL0533 |
| Lot Number | U1302117 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS MEDICAL LTD. |
| Manufacturer Address | FORTRAN RD., ST. MELLONS CARDIFF CF3OLT UK CF3 OLT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-11-19 |