MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-11-15 for ETHICON MICRO FORCEPS EBF02 6601-105 manufactured by Gyrus Medical Inc..
[21274046]
This device was returned in a clean but used condition. The jaw tips are bent. When the jaws are closed they appear twisted. Visual inspection confirms that some insulation is missing. The shaft and electrodes were cut 3 inches from the distal end and disassembled. One electrode has approximately an 1/8" of insulation missing from 3/4 around. The insulation was retrieved out of the patient but not returned to us. The insulation appears to have been torn from the electrode, not a clean cut. Analysis has determined that the failure is not related to the manufacture of the device. The twisted jaws and torn insulation would indicate that the forceps may have gotten caught on some other instrument during the case.
Patient Sequence No: 1, Text Type: N, H10
[21490297]
It was reported by the affiliate during a bilateral ovarian cystectomy procedure the ebf02 was connected to the valleylab force fx generator, with bipolar setting at 20. While opening the jaw after the second activation, the plastic shielding tube was torn off the coating on the metal electrode. Coating fell into patient's body and was retrieved. Product was discarded after the incident and bipolar product from other brand name was used and finished the surgery. Detached coating length approximately 1. 5cm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183680-2013-00054 |
| MDR Report Key | 3554151 |
| Report Source | 06,07 |
| Date Received | 2013-11-15 |
| Date of Report | 2013-10-21 |
| Date of Event | 2013-09-25 |
| Date Mfgr Received | 2013-10-21 |
| Date Added to Maude | 2014-02-25 |
| 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. TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE ROAD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5088042739 |
| Manufacturer G1 | GYRUS MEDICAL INC. |
| Manufacturer Street | 6655 WEDGWOOD ROAD, SUITE 160 |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55311 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHICON MICRO FORCEPS EBF02 |
| Generic Name | ETHICON MICRO FORCEPS EBF02 |
| Product Code | HIN |
| Date Received | 2013-11-15 |
| Returned To Mfg | 2013-10-22 |
| Model Number | 6601-105 |
| Catalog Number | 6601-105 |
| Lot Number | K4CL22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS MEDICAL INC. |
| Manufacturer Address | 6655 WEDGWOOD ROAD MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-11-15 |