FDA.reportPublic FDA data

MAUDE MDR 9652660

MDR report key
9652660
Report number
9652660
Event key
0
Event type
3
Date of event
2019-12-26
Date received
2020-01-31
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OPERON D 830TABLE, OPERATING-ROOM, ELECTRICALBERCHTOLD HOLDING GMBHGDCOPERON D-SERIES* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-310

Event Narratives#

D

Patient 1

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.