MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-02-13 for CODMAN CLASSIC PLUS 363001 * manufactured by Symmetry Surgical (codman).
[3140075]
At the end of the surgical procedure, it was noted that part of the inside jaw of a needle holder was missing. It is unknown whether or not it was intact at the beginning of the case. The physician was notified. An abdominal x-ray was taken and read as negative by the radiologist as "no foreign body seen". What was the original intended procedure? Peritoneal dialysis catheter placement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2971596 |
| MDR Report Key | 2971596 |
| Date Received | 2013-02-13 |
| Date of Report | 2013-02-13 |
| Date of Event | 2013-02-11 |
| Report Date | 2013-02-13 |
| Date Reported to FDA | 2013-02-13 |
| Date Reported to Mfgr | 2013-02-21 |
| Date Added to Maude | 2013-02-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CODMAN CLASSIC PLUS |
| Generic Name | BIOPSY NEEDLE KIT |
| Product Code | HFB |
| Date Received | 2013-02-13 |
| Model Number | 363001 |
| Catalog Number | * |
| Lot Number | SN 9104N |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY SURGICAL (CODMAN) |
| Manufacturer Address | 3034 OWEN DRIVE ANTIOCH TN 37013 US 37013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-13 |