MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-28 for RECT1CON20 TUBING SET FOR RELIANCE 6000 SERIES ENDOSCOPE STORAGE CABINET manufactured by Steris Canada Corporation.
[184679413]
A steris account manager provided the customer with replacement tubing sets. The conditions of the reported event are currently under evaluation; a follow-up mdr will be submitted when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[184679474]
The user facility reported via user facility medwatch report number mw5092247 that the rect1con20 tubing sets for their reliance 6000 series endoscope storage cabinet were breaking following sterilization. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2020-00007 |
| MDR Report Key | 9771597 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-01-02 |
| Date Mfgr Received | 2020-01-29 |
| Date Added to Maude | 2020-02-28 |
| 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 | MR. DANIEL DAVY |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR, OH |
| Manufacturer Country | US |
| Manufacturer Phone | 3927453 |
| Manufacturer G1 | STERIS CANADA CORPORATION |
| Manufacturer Street | 490, ARMAND-PARIS |
| Manufacturer City | QUEBEC, GIC 8A3 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | GIC 8A3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RECT1CON20 TUBING SET FOR RELIANCE 6000 SERIES ENDOSCOPE STORAGE CABINET |
| Generic Name | TUBING SET |
| Product Code | JRJ |
| Date Received | 2020-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CANADA CORPORATION |
| Manufacturer Address | 490 ARMAND-PARIS QUEBEC, GIC 8A3 CA GIC 8A3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-28 |