MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-02 for TONSIL SNARE manufactured by Aesculap.
[50914512]
Patient Sequence No: 1, Text Type: N, H10
[50914513]
A new snare gun was used in the bilateral tonsillectomy procedure that was scheduled. Per surgeon, the snare gun misfired and the snare wire used "sheard" surrounding tissue of the tonsils, causing additional bleeding. Surgeon used additional cautery to cauterize injured vessels. This prolonged the procedure time, thus prolonging anesthesia time. After the event in the operating room: aesculap sent the guns to their quality control department. Aesculap's qc sent them to (b)(4). Aesculap informed us that our original guns will be quarantined for a year. Aesculap sent us two new guns to replace the faulty guns. Aesculap claims the guns were not working correctly because we were using bausch & lomb wire. Md agreed to trial the aesculap guns with aesculap snare wires. Aesculap guns again didn't work correctly with the aesculap.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5839399 |
| MDR Report Key | 5839399 |
| Date Received | 2016-08-02 |
| Date of Report | 2016-07-27 |
| Date of Event | 2016-06-29 |
| Report Date | 2016-07-27 |
| Date Reported to FDA | 2016-07-27 |
| Date Reported to Mfgr | 2016-07-27 |
| Date Added to Maude | 2016-08-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | TONSIL SNARE |
| Product Code | KBZ |
| Date Received | 2016-08-02 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP |
| Manufacturer Address | 3773 CORPORATE PARKWAY CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-02 |