MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-15 for OPERON D 830 US SEAT, CFK OT 8302075 manufactured by Berchtold Gmbh & Co. Kg.
[176560075]
It was reported that "during a procedure yesterday the table dropped quickly from a mid-height to it's lowest height. It has been reported that the patient was open and there were instruments in the belly at the time of the event. It was reported to the complainant that the gall bladder ruptured as a result. No further information is known at this time. " an investigation is in process and stryker will file a supplemental at the conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[176560076]
It was reported that "during a procedure yesterday the table dropped quickly from a mid-height to it's lowest height. It has been reported that the patient was open and there were instruments in the belly at the time of the event. It was reported to the complainant that the gall bladder ruptured as a result. No further information is known at this time. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010153-2020-00001 |
| MDR Report Key | 9591778 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-15 |
| Date of Event | 2019-12-26 |
| Date Mfgr Received | 2019-12-26 |
| Date Added to Maude | 2020-01-15 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. VOLKER HORNSCHEIDT |
| Manufacturer Street | LUDWIGSTALER STRASSE 25 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Postal | 78532 |
| Manufacturer Phone | 74611810 |
| Manufacturer G1 | BERCHTOLD GMBH & CO. KG |
| Manufacturer Street | LUDWIGSTALER STRASSE 25 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPERON D 830 US SEAT, CFK |
| Generic Name | TABLE, OPERATING-ROOM, ELECTRICAL |
| Product Code | GDC |
| Date Received | 2020-01-15 |
| Catalog Number | OT 8302075 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BERCHTOLD GMBH & CO. KG |
| Manufacturer Address | LUDWIGSTALER STRASSE 25 TUTTLINGEN 78532 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-15 |