MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2014-09-12 for HEANEY-BALLANTINE FORCEPS 19-5505 manufactured by Symmetry Surgical, Inc..
[5073393]
Dr. Said clamp tip was breaking while in use in vagina though uterus was already out of patient. Then she took out clamp and tip that broke off. Instrument used in total vaginal hyst. Device failed (e. G. Broke, could not get it to work or stopped working). Device malfunction: the device did not do what ti was supposed to do.
Patient Sequence No: 1, Text Type: D, B5
[12533242]
Device was not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007208013-2014-00015 |
| MDR Report Key | 4232778 |
| Report Source | 00,06 |
| Date Received | 2014-09-12 |
| Date of Report | 2014-09-10 |
| Date of Event | 2014-06-02 |
| Date Mfgr Received | 2014-09-02 |
| Date Added to Maude | 2014-11-12 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHRIS SMITH |
| Manufacturer Street | 3034 OWEN DR |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal | 37013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEANEY-BALLANTINE FORCEPS |
| Generic Name | FORCEPS |
| Product Code | GZX |
| Date Received | 2014-09-12 |
| Model Number | 19-5505 |
| Catalog Number | 19-5505 |
| Lot Number | NA |
| ID Number | 008874820000601 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY SURGICAL, INC. |
| Manufacturer Address | ANTIOCH TN 37013 US 37013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-12 |