MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,user facility report with the FDA on 2016-08-18 for BALLENGER SWIVEL KNIFE BAYONET BLADE 3MM RH765-005 manufactured by Oertel Medical Gmbh.
[52401607]
(b)(4) on 12july2016, customer advocacy sent the customer an email acknowledging receipt of the complaint, providing the complaint number, and inquiring if additional information may be available. Confirmation was also requested from the customer that there was no patient impact associated with reported issue. Device not yet evaluated, if the device is evaluated a follow up will be sent.
Patient Sequence No: 1, Text Type: N, H10
[52401608]
Sales rep reported via email that the blade is broken off. On 10aug2016 additional information: i know it was a sinus case with dr. (b)(6). I believe they did an x-ray, and i know they did not find it in the patient. They completed the surgery as planned, and i never heard anything after incident, so i believe all is well with patient. If you need more information, please let me know and i will ask lead or coordinator to respond also.
Patient Sequence No: 1, Text Type: D, B5
[54165177]
(b)(4). The sample was provided and an evaluation was performed. The instrument was manufactured in march of 2010. The swivel knife is showing signs of wear. It appears as though there was too much pressure applied to the instrument, and perhaps the usage was incorrect. The instrument needs to be inspected before and after each use. There have been no issues identified with the material or manufacturing process. A review of the device history records (dhr) did not identify and issues that would have contributed to the reported issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423507-2016-00063 |
| MDR Report Key | 5885470 |
| Report Source | CONSUMER,USER FACILITY |
| Date Received | 2016-08-18 |
| Date of Report | 2016-09-08 |
| Date of Event | 2016-07-11 |
| Date Mfgr Received | 2016-08-10 |
| Device Manufacturer Date | 2010-03-01 |
| Date Added to Maude | 2016-08-18 |
| 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 | ANNA WEHRHEIM |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8473628063 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60061 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BALLENGER SWIVEL KNIFE BAYONET BLADE 3MM |
| Generic Name | KNIFE, NASAL |
| Product Code | KAS |
| Date Received | 2016-08-18 |
| Model Number | RH765-005 |
| Lot Number | XODM03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OERTEL MEDICAL GMBH |
| Manufacturer Address | OBERE VORSTADT 19 TUTTLINGEN 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-18 |