MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-10-19 for BOVIE AA01 manufactured by Symmetry Surgical, Inc.
[126106191]
On (b)(6) 2018 it was communicated to symmetry surgical that this complaint was being canceled as the pencils are now working with no issues. The medical staff has deemed the inability to activate the devices as user error. However, as a result a delay in surgery still occurred. No further actions are required. This can be seen as the final report. If additional information is obtained that alleges the need for corrective actions or indicates a risk to patient safety, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[126106192]
The customer alleged during a procedure, that the cauterizing pens were dying very quickly. They had to open seven pens during the procedure and the eighth one worked long enough to complete the surgery. As a result there was a delay in the procedure. There was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007208013-2018-00023 |
| MDR Report Key | 7986619 |
| Report Source | USER FACILITY |
| Date Received | 2018-10-19 |
| Date of Report | 2018-10-24 |
| Date of Event | 2018-09-19 |
| Date Mfgr Received | 2018-09-24 |
| Date Added to Maude | 2018-10-19 |
| 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 | BRANDI MEATH |
| Manufacturer Street | 3034 OWEN DRIVE |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal | 37013 |
| Manufacturer Phone | 6159645560 |
| Manufacturer G1 | BOVIE MEDICAL |
| Manufacturer Street | 5115 ULMERTON RD |
| Manufacturer City | CLEARWATER FL 33760 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33760 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BOVIE |
| Generic Name | CAUTERY PENCIL |
| Product Code | HQP |
| Date Received | 2018-10-19 |
| Catalog Number | AA01 |
| Lot Number | 0618G |
| Operator | HEALTH PROFESSIONAL |
| 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 | 3034 OWEN DRIVE ANTIOCH TN 37013 US 37013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-10-19 |