MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2006-06-19 for ULTRACISION SURG DEV, BLADES 10MM REUSABLE, OPEN DH010 manufactured by Ethicon Endo Surgery, Inc.(cincinnati).
[487941]
During a cholecystectomy procedure no function after a few minutes. A new device was used to complete the case with no adverse pt consequence. There is no further info available.
Patient Sequence No: 1, Text Type: D, B5
[7778440]
Based on analysis results, this complaint is now determined to be a mdr malfunction. The analysis results found that the device was returned with the blade scratched and cracked. The device was tested with a generator and an error code 5 was received. The identified blade damage may have occurred from external contact during pre-op or general use. In addition, minor blade damage may increase in severity during subsequent activations, and may result in blade "lockout" later in the procedure. Therefore, the instructional insert states: "scratches on the blade may lead to premature blade failure" and "avoid accidental contact with other instruments during use. " the batch record was reviewed and no anomalies were noted during the mfg process. 510(k) number is k990362.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1527736-2006-02764 |
| MDR Report Key | 727249 |
| Report Source | 01,07 |
| Date Received | 2006-06-19 |
| Date of Report | 2006-04-21 |
| Date Mfgr Received | 2006-06-07 |
| Device Manufacturer Date | 2005-04-01 |
| Date Added to Maude | 2006-06-22 |
| 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.(INDEPENDENCIA) |
| Manufacturer Street | BLVD INDEPENDENCIA #1151 |
| Manufacturer City | JUAREZ CHIHUAHUA MEXICO |
| Manufacturer Country | MX |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRACISION SURG DEV, BLADES 10MM REUSABLE, OPEN |
| Generic Name | GEO |
| Product Code | GEO |
| Date Received | 2006-06-19 |
| Returned To Mfg | 2006-05-26 |
| Model Number | NA |
| Catalog Number | DH010 |
| Lot Number | UNK |
| ID Number | BATCH=Y93Z5R |
| Device Expiration Date | 2010-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 715679 |
| Manufacturer | ETHICON ENDO SURGERY, INC.(CINCINNATI) |
| Manufacturer Address | * CINCINNATI OH * US |
| Baseline Brand Name | HARMONIC SCALPEL 10MM DISSECTING HOOK |
| Baseline Generic Name | ELECTRO-SURGERY ACCESSORIES |
| Baseline Model No | DH010 |
| Baseline Catalog No | DH010 |
| Baseline ID | * |
| Baseline Device Family | ELECTRO-SURGERY ACCESSORIES - ENDOS |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K904993 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 1 | 2006-06-19 |