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 2018-02-09 for RADIAL JAW? 4 M00515032 manufactured by Boston Scientific - Costa Rica (coyol).
[99948232]
The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[99948233]
It was reported to boston scientific corporation that a radial jaw 4 hot biopsy forceps was unpacked on (b)(6) 2018. According to the complainant, during unpacking, it was noticed that there was tear in the device packaging and sterility of the device was compromised. There was no patient or procedure involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-00333 |
| MDR Report Key | 7258533 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-02-09 |
| Date of Report | 2018-01-23 |
| Date of Event | 2018-01-20 |
| Date Mfgr Received | 2018-03-10 |
| Device Manufacturer Date | 2017-04-07 |
| Date Added to Maude | 2018-02-09 |
| 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 | EMP. NANCY CUTINO |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Manufacturer G1 | BOSTON SCIENTIFIC - COSTA RICA (COYOL) |
| Manufacturer Street | 2546 FIRST STREET PROPARK FREE ZONE |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RADIAL JAW? 4 |
| Generic Name | FORCEPS, BIOPSY, ELECTRIC |
| Product Code | KGE |
| Date Received | 2018-02-09 |
| Returned To Mfg | 2018-02-23 |
| Model Number | M00515032 |
| Lot Number | 20492289 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - COSTA RICA (COYOL) |
| Manufacturer Address | 2546 FIRST STREET PROPARK FREE ZONE ALAJUELA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-09 |