MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2010-03-31 for SKINTACT WR01 manufactured by Leonhard Lang Gmbh.
[1298887]
On (b) (6) 2010, a 30 minutes vaginal hysterectomy was performed at (b) (6) hospital, (b) (6). An eschmann td 830 electrosurgical generator and a non monitoring dispersive electrode (model wr01) were used. The electrode was placed on the upper right thigh. The pt was in the lithotomy position and was not repositioned. The pt is normal (b) (6) built and has a normal dry skin. The skin was not cleaned, not disinfected and not shaving. Toward the end of the procedure, the surgeon noticed a loss in coagulation effect and shortly afterwards an alarm went off. It was discovered that the electrode had almost entirely come off. A line of blisters including a third degree burn of app 10 sqmm was discovered underneath. Another electrode of the same lot was applied on the other thigh and the procedure was completed. According to the info provided by the hospital the burn was not treated.
Patient Sequence No: 1, Text Type: D, B5
[8489585]
The device in the incident and the retained samples of the same lot have been tested visually, electrically and thermally. Mechanical tests were performed on 3 retained samples (the device involved in the incident was in an state not suitable for the mechanical test). All samples were fine to perform within the limits. No faults could be detected. It appears that the user did not follow the ifu of the product: when a loss of coag was effect was not checked immediately but the power increased from 30 to 40 (user questionnaire and user incident report to (b) (6)). The ifu specifically states "should (. . . ) coagulation effect diminish during surgery (. . . ) a problem may exist. Immediately make sure that the dispersive electrode [=grounding plate] is (. . . ) in full contact with the skin. " the eschmann td830 is equipped with an electrode contact quality monitoring system, which only works with a monitoring electrode ("split"). An unsplit non-monitoring electrode was used. The ifu specifically states "if an electrosurgical unit offers an electrode cqms (. . . ) always use a split electrode. " the use of a split plate would have avoided the burn. Immediately checking the plate site when the loss of the coagulation effect was discovered might have reduced or avoided the burn. We, therefore, conclude that a user error, specifically not following the ifu, at least contributed to incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8020045-2010-00001 |
| MDR Report Key | 1651758 |
| Report Source | 01,08 |
| Date Received | 2010-03-31 |
| Date of Report | 2010-03-26 |
| Date of Event | 2010-02-24 |
| Date Mfgr Received | 2010-02-25 |
| Device Manufacturer Date | 2009-11-01 |
| Date Added to Maude | 2010-04-08 |
| 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 | MR. BURRHUS LANG |
| Manufacturer Street | ARCHENWEG 56 |
| Manufacturer City | INNSBRUCK 6020 |
| Manufacturer Country | AU |
| Manufacturer Postal | 6020 |
| Manufacturer Phone | 12334257 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKINTACT |
| Generic Name | ELECTROSURGICAL GROUNDING PLATE |
| Product Code | ODR |
| Date Received | 2010-03-31 |
| Returned To Mfg | 2010-03-18 |
| Model Number | WR01 |
| Catalog Number | WR01 |
| Lot Number | 91127-0813 |
| Device Expiration Date | 2012-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEONHARD LANG GMBH |
| Manufacturer Address | ARCHENWEG 56 INNSBRUCK 6020 AU 6020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-03-31 |