MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-05-14 for ETHICON CORD 6999-105 manufactured by Gyrus Medical Inc..
[3565188]
It was reported to gyrus (b)(4) that during a laparoscopic myomectomy, there was a larger spark between jaws than usual. The jaws got burned. The device had difficulty in sealing. Another device was used to complete the procedure. There was no harm to the patient. There are three devices associated with this incident. Please see the following mfr. Report numbers: 2183680-2013-00024, 00025, 00026.
Patient Sequence No: 1, Text Type: D, B5
[10741341]
The appearance of the cord indicates it has been used and re-processed numerous times, this is a re-usable product, there is no way to tell the number of times the cord as been processed, ifu indicates that the cord is designed and rated for 20 uses, the banana plug connectors are pitted due to multiple autoclave cycles, device connector end does not indicate wear, continuity checks are good on both plugs, no shorting observed. Cord works as designed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183680-2013-00025 |
| MDR Report Key | 3124506 |
| Report Source | 06,07 |
| Date Received | 2013-05-14 |
| Date of Report | 2013-04-30 |
| Date of Event | 2013-03-22 |
| Date Mfgr Received | 2013-04-30 |
| Date Added to Maude | 2013-05-23 |
| 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 RD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5088042739 |
| Manufacturer G1 | GYRUS MEDICAL INC. |
| Manufacturer Street | 6655 WEDGWOOD ROAD |
| Manufacturer City | MAPLE GROVE MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHICON CORD |
| Generic Name | CORD |
| Product Code | HIN |
| Date Received | 2013-05-14 |
| Returned To Mfg | 2013-05-02 |
| Model Number | 6999-105 |
| Catalog Number | 6999-105 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2013-05-14 |