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 2020-02-06 for RADIAL JAW 4 M00515181 1518 manufactured by Boston Scientific Corporation.
[178182806]
The device has been received for analysis. Upon completion of the failure analysis of the complaint device, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[178182807]
It was reported to boston scientific corporation that a radial jaw 4 pulmonary biopsy forceps was used in the lungs during a bronchoscopy with biopsy procedure performed on (b)(6) 2020. According to the complainant, during the procedure, a biopsy was performed for a suspected malignant tumor. After the first biopsy, the site began to bleed. Ice water flush was used to slow the bleeding. A second biopsy was then taken and more bleeding occurred. Ice water flushes were used again. A rapid response team was called and the patient was stabilized. The patient was then brought to the post anesthesia care unit and was released from the hospital on the same day. There were no reported issues with the device. No further information has been obtained despite good faith efforts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00203 |
| MDR Report Key | 9679710 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-06 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-01-10 |
| Date Mfgr Received | 2020-02-07 |
| Device Manufacturer Date | 2019-10-15 |
| Date Added to Maude | 2020-02-06 |
| 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 | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | BOSTON SCIENTIFIC DE COSTA RICA S.R.L. |
| Manufacturer Street | 2546 CALLE PRIMERA |
| 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, NON-ELECTRIC |
| Product Code | FCL |
| Date Received | 2020-02-06 |
| Returned To Mfg | 2020-02-03 |
| Model Number | M00515181 |
| Catalog Number | 1518 |
| Lot Number | 0024603584 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-06 |