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 MAXI-FORCEPS 6602-105 manufactured by Gyrus Medical, Inc..
[3450029]
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 pt. There are three other devices associated with this incident. Please see the following mfr. Report numbers: 2183680-2013-00024, 2183680-2013-00025, 2183680-2013-00026.
Patient Sequence No: 1, Text Type: D, B5
[10721682]
Device returned in a clean state, no coag build up on the jaws, jaws open/close, rotate as designed, kynar insulation is in place, using the cord that was returned by the customer, the device was connected to the generator set at 24 watts coag, device activated and coagulated as designed. No loss of coagulation function or sparking was seen during functional testing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183680-2013-00024 |
| MDR Report Key | 3124708 |
| 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 ROAD |
| Manufacturer City | SOUTHBOROUGH MO 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 MAXI-FORCEPS |
| Generic Name | MAXI-FORCEPS |
| Product Code | HIN |
| Date Received | 2013-05-14 |
| Returned To Mfg | 2013-05-02 |
| Model Number | 6602-105 |
| Catalog Number | 6602-105 |
| Lot Number | JF500328 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2013-05-14 |