MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-31 for OPERON D 830 OPERON D-SERIES manufactured by Berchtold Holding Gmbh.
[177153420]
Operation room bed caused shifting of bed during procedure with sudden movement of patient & rupture of gall bladder. During lap choley a new stryker bed was being positioned by surgeon into trendelenberg position with remote and a large cracking noise noted and the bed fell about 1 foot (surgeon had hold of the gallbladder w/grasper), causing gallbladder to rupture spilling bilious fluid/stones into peritoneum. Patient will be monitored for possible infections. Manufacturer response for operating table, operon d 830 (per site reporter). Stryker has been to site to look at the bed. They've been actively involved with review.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9652660 |
| MDR Report Key | 9652660 |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-06 |
| Date of Event | 2019-12-26 |
| Report Date | 2020-01-06 |
| Date Reported to FDA | 2020-01-06 |
| Date Reported to Mfgr | 2020-01-31 |
| Date Added to Maude | 2020-01-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPERON D 830 |
| Generic Name | TABLE, OPERATING-ROOM, ELECTRICAL |
| Product Code | GDC |
| Date Received | 2020-01-31 |
| Model Number | OPERON D-SERIES |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BERCHTOLD HOLDING GMBH |
| Manufacturer Address | 2825 AIRVIEW BLVD PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-31 |