MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-20 for SURGISTOOL 0830000000 manufactured by Stryker Medical-kalamazoo.
[120975508]
It was alleged that the surgistool seat was potentially loose and leans forward when in use. No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
Patient Sequence No: 1, Text Type: D, B5
[131587433]
After investigation, it was identified that the surgistool allegedly leaning forward was not due to any specific component malfunction. After communication with the customer, it was determined that the issue was not due to the product as a nurse had placed additional padding on the seat, causing the surgeon to feel a slight incline forward while sitting.
Patient Sequence No: 1, Text Type: N, H10
[131587434]
It was alleged that the surgistool seat was potentially loose and leans forward when in use. No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2018-01048 |
| MDR Report Key | 7893138 |
| Date Received | 2018-09-20 |
| Date of Report | 2018-11-29 |
| Date of Event | 2018-08-22 |
| Date Mfgr Received | 2018-08-22 |
| Device Manufacturer Date | 2018-02-23 |
| Date Added to Maude | 2018-09-20 |
| 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 | MR. BRIAN THOMPSON |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693292100 |
| Manufacturer G1 | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SURGISTOOL |
| Generic Name | STOOL, OPERATING-ROOM |
| Product Code | FZM |
| Date Received | 2018-09-20 |
| Catalog Number | 0830000000 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Address | 3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-20 |