MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-12-11 for POLYHESIVE RETURN ELECTRODE E7506 manufactured by Covidien Lp (valleylab).
[1256778]
The customer reported that during an orthopedic case on the right hip to remove a tumor, the patient sustained an injury at the pad location. Two generators were in use, another co's abc argon unit and a covidien electrosurgical generator. The patient was in a lateral position with the left side down. The or record indicates that the covidien generator pad was on the anterior left thigh while another co's pad was on the left posterior thigh. The lesion is reported to be on the posterior thigh. However, the initial reporter stated that in a verbal conversation with the nurses in the or, they stated that the pads were actually placed on the patient opposite of what the or record indicates. This would mean the abc pad was on the anterior thigh and the esu pad was on the posterior thigh. The extent of the injury was unknown, but a plastic surgeon was called in and the patient will need additional surgery.
Patient Sequence No: 1, Text Type: D, B5
[8505582]
The site has indicated that the pad is not available for evaluation. The e7506 is a non-rem pad and therefore, the generator can not detect if the impedance of the return circuit is such that a burn is possible. If the pad were to come loose during a procedure, the current could have concentrated in the remaining patient contact area of the pad and result in a burn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2009-00615 |
| MDR Report Key | 1560333 |
| Report Source | 05,06 |
| Date Received | 2009-12-11 |
| Date of Report | 2009-11-12 |
| Date of Event | 2009-11-01 |
| Date Mfgr Received | 2009-11-12 |
| Date Added to Maude | 2009-12-18 |
| 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-MANAGER |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| 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 | 2009-12-11 |
| Catalog Number | E7506 |
| Lot Number | UNKNOWN |
| 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 DRIVE BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2009-12-11 |