MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-02 for PK CUTTING FORCEPS, 5MM, 33CM PK-CF0533 manufactured by Osta.
[47606889]
Lot pw301382. The instrument burnt without contact. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[50827407]
Left side of blue coag button has no tactile feel, right side is good. Complaint is confirmed, upon plugging the device into the generator it activates with out touching the blue coag button. Removed coag button, collapsed left side dome switch on the flex circuit.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003790304-2016-00004 |
| MDR Report Key | 5694404 |
| Date Received | 2016-06-02 |
| Date of Report | 2016-08-01 |
| Date of Event | 2016-02-26 |
| Date Mfgr Received | 2016-07-27 |
| Date Added to Maude | 2016-06-02 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE ROAD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 508804-273 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PK CUTTING FORCEPS, 5MM, 33CM |
| Product Code | EMH |
| Date Received | 2016-06-02 |
| Model Number | PK-CF0533 |
| Lot Number | PWO301382 |
| ID Number | UDI |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTA |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-02 |