MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-14 for ULTRACISION SURGERY REUSABLE DEVICES, HANDPIECE 54,55 HP054 manufactured by Ethicon Endo Surgery, Inc. (cincinnati).
[37612520]
(b)(4). Info not provided during initial contact.
Patient Sequence No: 1, Text Type: N, H10
[37612521]
It was reported that the 4-40 stud broke as the customer was disassembling the instrument after a case. There was no pt involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1527736-2004-03078 |
| MDR Report Key | 5310724 |
| Date Received | 2004-09-14 |
| Date of Report | 2004-09-07 |
| Date of Event | 2004-09-04 |
| Date Mfgr Received | 2004-09-07 |
| Device Manufacturer Date | 2003-08-01 |
| Date Added to Maude | 2015-12-18 |
| 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 | GARY LEBLANC |
| Manufacturer Street | 4545 CREEK RD. |
| Manufacturer City | CINCINNATI OH 45242 |
| Manufacturer Country | US |
| Manufacturer Postal | 45242 |
| Manufacturer Phone | 5133378582 |
| Manufacturer G1 | ETHICON ENDO SURGERY, INC. (INDEPENDENCIA) |
| Manufacturer Street | BLVD INDEPENDENCIA #1151 |
| Manufacturer City | JUAREZ CHIHUAHUA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ULTRACISION SURGERY REUSABLE DEVICES, HANDPIECE 54,55 |
| Generic Name | HAND PIECE |
| Product Code | HBD |
| Date Received | 2004-09-14 |
| Model Number | NA |
| Catalog Number | HP054 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO SURGERY, INC. (CINCINNATI) |
| Manufacturer Address | CINCINNATI OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-09-14 |