MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-10-03 for HI PWR DISPOSBL GRNDING PAD DGPHP manufactured by Covidien Lp.
[4966178]
The customer reported that it was observed the grounding plat had light and dark spots. The grounding plate could not be used. No patient injury occurred. Covidien's initial evaluation of the incident sample found it was degraded with no continuity.
Patient Sequence No: 1, Text Type: D, B5
[12424753]
(b)(4). One dgphp patient return electrode pad was returned for evaluation. The foil was degraded under the termination cover. The resistance was measured and was out of specification. Investigation identified minute levels of chloride contamination as a possible contributor to the degradation. A supplier corrective action request (scar) was issued to the supplier to eliminate the source of the contamination. A health hazard evaluation (hhe) was performed to determine patient risk of existing product on the market. The risk of possible injury with the degraded product was evaluated and determined to be far lower than the general risk of injury reported in independent literature for use of these types of patient return electrodes. The risk is further reduced by visual determination of foil discoloration/degradation by the clinician prior to use. A product recall was conducted in august 2012.
Patient Sequence No: 1, Text Type: N, H10
[12486325]
(b)(4). Date of initial report: (b)(4) 2014. The incident device ha been received and is under evaluation. When the device evaluation is complete a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2014-00822 |
| MDR Report Key | 4137816 |
| Report Source | 01,05,06 |
| Date Received | 2014-10-03 |
| Date of Report | 2014-09-08 |
| Date of Event | 2012-06-26 |
| Date Mfgr Received | 2014-09-29 |
| Device Manufacturer Date | 2010-12-21 |
| Date Added to Maude | 2014-10-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHARON MURPHY |
| Manufacturer Street | 5920 LONGBOW DR. |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 2034925267 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HI PWR DISPOSBL GRNDING PAD |
| Generic Name | RF ABLATION BROUDING PAD |
| Product Code | ODR |
| Date Received | 2014-10-03 |
| Returned To Mfg | 2014-09-05 |
| Catalog Number | DGPHP |
| Lot Number | 199011 |
| Device Expiration Date | 2013-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP |
| Manufacturer Address | 5920 LONGBOW DR. BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-03 |