MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for EDGE E1455 manufactured by Covidien Mfg Dc Boulder.
[185709822]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185709823]
According to the reporter, during a procedure, the insulator of the two electrodes broke and fell into the patient's cavity. The broken piece was fully retrieved, and an x-ray was not performed to locate it. A picture of the electrodes was submitted and it showed the broken insulator of one of the reported product. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[188675295]
Evaluation summary: the product was not returned; however, a picture was provided by the customer for analysis. The product in the picture did not meet specification. Visual inspection found the blue heat shrink to have been scratched and damaged allowing the ptfe insulator to get torn and fall off. The reported condition was confirmed. Inspection found the blue insulation was scratched. The ptfe insulator came off. The blue heat shrink insulation holds the ptfe in place and damage to the insulation can cause the clear insulation to be torn. The damage to the electrode indicates the user mishandled the electrodes. It also may have been cleaned with an abrasive material. This cleaning method would also contribute to the insulator disengaging. The device failed hipot testing at the scratch sites on the blue insulation. The investigation identified the root cause of the reported event to be attributed to user handling damage. The instructions for use (ifu) states: the electrode has a coating to reduce sticking of eschar. Cleaning the electrode with a scratch pad or other abrasive object, scraping with a sharp object or bending beyond 90 degrees may damage the electrode. If the electrode is damaged, discard it. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188675296]
According to the reporter, during a procedure, the insulator of the two electrodes broke and fell into the patient's cavity. The broken piece was fully retrieved, and an x-ray was not performed to locate it. There was no further medical or surgical intervention done to retrieved the disengaged piece. They used a third electrode to complete the procedure. A picture of the electrodes was submitted and it showed the broken insulator of one of the reported product. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1717344-2020-00358 |
| MDR Report Key | 9902222 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-12 |
| Date Mfgr Received | 2020-03-12 |
| Date Added to Maude | 2020-03-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA HERNANDEZ |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | COVIDIEN MFG DC BOULDER |
| Manufacturer Street | 5920 LONGBOW DR |
| Manufacturer City | BOULDER CO 803013299 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 803013299 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EDGE |
| Generic Name | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
| Product Code | GEI |
| Date Received | 2020-03-31 |
| Model Number | E1455 |
| Catalog Number | E1455 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN MFG DC BOULDER |
| Manufacturer Address | 5920 LONGBOW DR BOULDER CO 803013299 US 803013299 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |