MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-04-02 for HEDGEHOG SBB-382-50 60252 manufactured by Boston Scientific Corporation.
[140635973]
This is a non-sterile device with no expiration date. (b)(4). 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
[140635974]
It was reported to boston scientific corporation that a hedgehog double bundle brush was used during washing of the scope on (b)(6) 2019. According to the complainant, during washing of the endoscope, it was noted that bristles from the brush detached. Another brush was used to complete the cleaning of the scope. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-01600 |
| MDR Report Key | 8473937 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-02 |
| Date of Report | 2019-05-13 |
| Date of Event | 2019-03-07 |
| Date Mfgr Received | 2019-04-18 |
| Device Manufacturer Date | 2018-04-14 |
| Date Added to Maude | 2019-04-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | SUZHOU TEMEIRUI MEDICAL PRODUCTS CO., LTD |
| Manufacturer Street | NO 699 PINAN ROAD PUZHAUNG LINHU TOWN, |
| Manufacturer City | WUZHONG DISTRICT, SUZHOU 21505 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 21505 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEDGEHOG |
| Generic Name | ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE |
| Product Code | MNL |
| Date Received | 2019-04-02 |
| Returned To Mfg | 2019-04-01 |
| Model Number | SBB-382-50 |
| Catalog Number | 60252 |
| Lot Number | 0000180409 |
| 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 CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY , MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-02 |