MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-16 for ULTRACISION SURGERY REUSABLE DEVICES, HANDPIECES HP053 manufactured by Ethicon Endo-surgery, Inc..
[37096360]
(b)(4) information not provided during initial contact. Result: collapsed isolator. Analysis summary: the hand piece was returned with a loose mount. The handpiece was tested for impedance and failed the test. The instrument was disassembled, moisture and a collapsed isolator were found in the instrument.
Patient Sequence No: 1, Text Type: N, H10
[37096361]
It was reported that the customer gave her a hand piece for disposal that had a problem at some unknown time in the past. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1527736-2004-03105 |
| MDR Report Key | 5328943 |
| Date Received | 2004-09-16 |
| Date of Report | 2004-09-13 |
| Date Mfgr Received | 2004-09-13 |
| Device Manufacturer Date | 2001-09-01 |
| Date Added to Maude | 2015-12-28 |
| 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 |
| 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, HANDPIECES |
| Generic Name | HAND PIECE |
| Product Code | HBD |
| Date Received | 2004-09-16 |
| Returned To Mfg | 2004-08-18 |
| Model Number | NA |
| Catalog Number | HP053 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2004-09-16 |