MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-30 for HI-LINE XXS DIAM. NEURO CUTTER III D3.OMM GE843SU manufactured by Aesculap, Inc..
[23134522]
Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[23134523]
Tip broke during surgery. No patient injury or surgical delays. Add'l components in use: gb790r/hi-line xxs handpiece. Gd675/microspeed uni xs highspeed motor (s/n (b)(4)). Gb794r/hi-line xxs handpiece shaft curved iii (s/n (b)(4)).
Patient Sequence No: 1, Text Type: D, B5
[35759496]
Manufacturing site evaluation: the burr was investigated and it was detected that the burr head was broken off. The breakage is located approximately 13 millimeters from the burr head to the middle of the product. The breakage surface was checked and follows the pattern of a forced fracture, very likely caused by high lateral forces applied to the tool. This corresponds to the findings of the handpiece gb794r (below). Indications of a material or manufacturing defect were not found. Additional components : gd675: functions as intended. Gb790r: functions as intended. Gb793r: functions as intended; however, shows signs of normal wear from use. Gb794r: found to be damaged; some parts missing from the tip.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2015-00641 |
| MDR Report Key | 4963932 |
| Date Received | 2015-07-30 |
| Date of Report | 2016-01-12 |
| Date of Event | 2015-06-29 |
| Date Mfgr Received | 2015-06-30 |
| Date Added to Maude | 2015-08-04 |
| 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 | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP, INC. |
| Manufacturer Street | P.O. BOX 40 |
| Manufacturer City | TUTTLINGEN |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HI-LINE XXS DIAM. NEURO CUTTER III D3.OMM |
| Generic Name | BURR |
| Product Code | HTT |
| Date Received | 2015-07-30 |
| Model Number | GE843SU |
| Catalog Number | GE843SU |
| Lot Number | 52015288 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP, INC. |
| Manufacturer Address | TUTTLINGEN, DE 78532 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-30 |