MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2010-08-07 for MAMM MR 8G BLADELESS PROBE SET MRP08S manufactured by Ethicon Endo-surgery, Llc..
[1631316]
It was reported the probe was getting intermittent samples and giving error codes during an mr assisted breast biopsy. The customer also noticed the clear probe mode wouldn't function correctly. The probe was removed from the patient's breast and it was noticed there were a lot of samples jammed into the end of the needle. The samples were removed from the probe and the customer discarded the probe before the device could be saved for return for analysis. The case was completed using a second probe with no consequence to the patient. Patient information was requested but little was provided.
Patient Sequence No: 1, Text Type: D, B5
[8795165]
(b)(4). Information is unavailable; device was not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005075853-2010-04500 |
| MDR Report Key | 1788336 |
| Report Source | 05,06,07 |
| Date Received | 2010-08-07 |
| Date of Report | 2010-07-13 |
| Date of Event | 2010-07-13 |
| Date Mfgr Received | 2010-07-13 |
| Device Manufacturer Date | 2009-08-13 |
| Date Added to Maude | 2010-12-02 |
| 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 | KATHY RICE |
| Manufacturer Street | 4545 CREEK RD |
| Manufacturer City | CINCINNATI OH 452422803 |
| Manufacturer Country | US |
| Manufacturer Postal | 452422803 |
| Manufacturer Phone | 5133373299 |
| Manufacturer G1 | ETHICON ENDO-SURGERY, LLC |
| Manufacturer Street | 475 CALLE C |
| Manufacturer City | GUAYNABO PR 00969 |
| Manufacturer Postal Code | 00969 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAMM MR 8G BLADELESS PROBE SET |
| Product Code | EXX |
| Date Received | 2010-08-07 |
| Model Number | NA |
| Catalog Number | MRP08S |
| Lot Number | F4PC0X |
| ID Number | BATCH # F9H907 |
| Device Expiration Date | 2014-07-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
| Manufacturer Address | 475 CALLE C GUAYNABO PR 00969 00969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-08-07 |