MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-24 for ULTRACISION SURGERY REUSABLE DEVICES, HANDPIECE 54,55 HP054 manufactured by Ethicon Endo-surgery, Inc..
[37526145]
Collapsed isolator. Analysis summary: the hand piece was returned with a loose mount. The hand piece was tested with a generator and an error code 3 was found. The instrument was disassembled, a collapsed isolator was found in the instrument.
Patient Sequence No: 1, Text Type: N, H10
[37526146]
It was reported that prior to the procedure, error code 3 consistently seen on screen. No patient consequence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1527736-2004-03217 |
| MDR Report Key | 5314017 |
| Date Received | 2004-09-24 |
| Date of Report | 2004-09-22 |
| Date of Event | 2004-06-01 |
| Date Mfgr Received | 2004-09-22 |
| Device Manufacturer Date | 2002-06-01 |
| Date Added to Maude | 2015-12-21 |
| 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 452422803 |
| Manufacturer Country | US |
| Manufacturer Postal | 452422803 |
| Manufacturer Phone | 5133378582 |
| Manufacturer G1 | ETHICON ENDO-SURGERY, INC. |
| Manufacturer Street | BLVD INDEPENDENCIA #1151 |
| Manufacturer City | JUAREZ CHIHUAHUA MEX ICO |
| 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 | 2004-09-24 |
| Returned To Mfg | 2004-09-20 |
| Model Number | NA |
| Catalog Number | HP054 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO-SURGERY, INC. |
| Manufacturer Address | CINCINNATI OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-09-24 |