MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2010-02-01 for POLYHESIVE RETURN ELECTRODE E7506 manufactured by Covidien Lp (valleylab).
[1283284]
The customer reported that, following a radio frequency liver ablation using a boston scientific ablation generator and a e7506 non-rem pad, they discovered a pt injury. The grounding pads were placed in parallel at the top of the pt's thighs. The 5. 0cm probe was used and the algorithm for the 5. 0cm probe was followed. The grounding pads were checked every 4-5 minutes. Activation was approximately 42 minutes. When the grounding pads were removed, a small area of erythema was present across the top of the legs and a 1 cm circumference skin break on the inside of the left thigh. Frozen saline was applied to the erythema and topical flamazine was used. The doctor expressed that he believes that the pads were to blame for the burn and that this is a risk of the procedure especially for longer activations with the 5cm probe. The four pads are on mfr report #s 1717344-2010-00006, 1717344-2010-00022, and 1717344-2010-00023.
Patient Sequence No: 1, Text Type: D, B5
[8451501]
(b)(4). The pads were discarded and no evaluation can be performed. The ifu states: non-traditional procedures that utilize high current, long duty cycles, or both (for example: tissue lesioning, tissue ablation, tissue vaporization, and procedure in which conductive fluids such as saline or lactated ringer's solution are introduced into the surgical site for distention or to conduct the rf current) increase the risk of excessive heating under a fully applied return electrode to the point of injuring the pt. Use of more than one pt return electrode may help mitigate the increased risk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2010-00024 |
| MDR Report Key | 1600723 |
| Report Source | 00 |
| Date Received | 2010-02-01 |
| Date of Report | 2010-01-04 |
| Date of Event | 2009-11-17 |
| Date Mfgr Received | 2010-01-04 |
| Device Manufacturer Date | 2009-01-01 |
| Date Added to Maude | 2010-09-16 |
| 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 | KIM SCHWARZ, MGR |
| Manufacturer Street | 5920 LONGBOW DR. |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3035306245 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLYHESIVE RETURN ELECTRODE |
| Generic Name | ELECTROSURGICAL ACCESSORY |
| Product Code | ODR |
| Date Received | 2010-02-01 |
| Catalog Number | E7506 |
| Lot Number | 154945 |
| Device Expiration Date | 2011-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP (VALLEYLAB) |
| Manufacturer Address | 5920 LONGBOW DR. BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-02-01 |