MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-06-12 for CASTLE M/C6927 WASHER/STERILIZER NA manufactured by Getinge/castle, Inc..
[95237]
Operator pressed cycle start and then adjusted load basket(s) within the chamber as power door was closing (raising). Basket(s) interfered with closind door; all four fingers of operator's right hand were caught/crushed between top of basket and top of washer/sterilizer chamber. Door was manually lowered by maintenance personnel, after some time. Medical intervention was seeked (er); operator was treated and released; extended medical leave; report of follow-up surgery on 5/14/98; as follow-up for 6/12/98 it was confirmed that 2-3 tips of operator's fingers were amputated on 5/14/98 and operator is on workman's compensation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 172244 |
| MDR Report Key | 172244 |
| Date Received | 1998-06-12 |
| Date of Report | 1998-06-12 |
| Date of Event | 1998-04-28 |
| Date Added to Maude | 1998-06-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CASTLE M/C6927 WASHER/STERILIZER |
| Generic Name | WASHER/STERILIZER |
| Product Code | FLH |
| Date Received | 1998-06-12 |
| Model Number | M/C6927 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 167494 |
| Manufacturer | GETINGE/CASTLE, INC. |
| Manufacturer Address | 1777 EAST HENRIETTA RD. ROCHESTER NY 146233133 US |
| Baseline Brand Name | CASTLE M/C6927 WASHER/STERILIZER |
| Baseline Generic Name | WASHER/STERILIZER |
| Baseline Model No | M/C927 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-06-12 |