MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-03-22 for YARARGIL MICRO DISSECTOR BAYO 7-1/4 ARACHNOID RB9344 manufactured by Integra York, Pa Inc..
[103531904]
Root cause cannot be determined due to the lack of information received to perform a complete investigation. There has been no manufacturing deficiency identified, the instrument has not been returned for evaluation. Linked manufacturing numbers: 2523190-2018-00038 and 2523190-2018-00037.
Patient Sequence No: 1, Text Type: N, H10
[103531905]
A customer reported on (b)(6) 2018, the stardust dnh str #278093, spring? S handle suddenly broke while the surgeon was suturing the patient. Also during use suspect device, rb9344 yarargil micro dissector bayo, tip broke and fell in the patient? S brain cavity. The surgeon retrieved the broken tip from the patient. It was noted there was a 15-minute delay of the surgery. The surgery was completed with other instruments and the patient was fine. This is one of two reports concerning the same patient and procedure using two integra devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2018-00037 |
| MDR Report Key | 7364097 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-03-22 |
| Date of Report | 2018-02-26 |
| Date of Event | 2018-02-15 |
| Date Mfgr Received | 2018-03-08 |
| Date Added to Maude | 2018-03-22 |
| 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 |
| Reporter Occupation | DENTAL HYGIENIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER KIMBERLY SHELLY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | YARARGIL MICRO DISSECTOR BAYO 7-1/4 ARACHNOID |
| Generic Name | MICRO DISSECTORS |
| Product Code | GZX |
| Date Received | 2018-03-22 |
| Catalog Number | RB9344 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-22 |