MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-10-10 for MINIMALLY INVASIVE SPINE SYSTEM N/A 14-500551 manufactured by Ebi, Llc..
[3072000]
It was reported that problems with the light source of the minimally invasive spine system caused a 30 minute delay in surgery. Patient outcome: no adverse effect reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[10279139]
No product was returned to manufacturer. Current information is insufficient to permit a conclusion as to the cause of the event. This is 1 of 3 mdrs involved in the same event. Please see mdr numbers:0002242816-2012-00068,0002242816-2012-00069,0002242816-2012-00070.
Patient Sequence No: 1, Text Type: N, H10
[10414676]
The device discarded and therefore an evaluation could not be performed. Due to the inability to evaluate device associated with the reported event, we are unable to provide a detailed analysis for the instrumentation. The manufacturing records were reviewed and there were no dimensional, functional, or material anomalies found in the documentation. The most probably root cause for the reported event is incorrect connection to unapproved light source. As reported, the system was incorrectly attached to a karl storz light source. Accuvision only comes with an acmi adapter. According to the reference guide and surgical technique: "accuvision lighted blade tips are sterile packed with a standard acmi adapter. A sterilized light cable needs to be supplied by the operating room to connect to the o. R. Supplied light source. Do not connect the lighted blade tip directly to the light source. " "the accuvision illuminated blade tip is intended for use with a 300 watt xenon illuminator, using a 3. 0mm fiber optic cable with a female acmi connector. " "the accuvision illuminated blade tip connects to a light source used for head lamps or endoscopes. A 3. 0mm fiber optic cable with an acmi fitting attaches the light source and accuvision illuminated blade tip. Make sure the lighted blade connector is securely attached to the cable. The cable should be in good repair with clean optics. Dirty optics or cables in need of repair can cause excessive heat at the connectors. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0002242816-2012-00070 |
| MDR Report Key | 2781225 |
| Report Source | 07 |
| Date Received | 2012-10-10 |
| Date of Report | 2012-09-11 |
| Date of Event | 2012-09-10 |
| Date Mfgr Received | 2012-09-11 |
| Device Manufacturer Date | 2012-08-16 |
| Date Added to Maude | 2013-01-24 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. DAVID TALISH |
| Manufacturer Street | 100 INTERPACE PARKWAY |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9732999300 |
| Manufacturer Country | US |
| Single Use | 0 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MINIMALLY INVASIVE SPINE SYSTEM |
| Generic Name | ACCUVISION BLADE TIP - FLAT |
| Product Code | FDG |
| Date Received | 2012-10-10 |
| Model Number | N/A |
| Catalog Number | 14-500551 |
| Lot Number | 833310 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EBI, LLC. |
| Manufacturer Address | 100 INTERPACE PARKWAY PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-10 |