FDA Adverse Event Death Summary report: N

KARL STORZ

MDR report key: 15658951 · Received October 24, 2022

Report

Report Number
MW5112794
Event Type
Death
Date Received
October 24, 2022
Date of Event
October 7, 2022
Report Date
October 20, 2022
Manufacturer
KARL STORZ SE&CO. KG / KARL STORZ ENDOSCOPY-AMERICA, INC.
Product Code
HFA
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
OR, US
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

PATIENT (B)(6) IS A G3P2002 AT 16W0D WITH MONOCHORIONIC DIAMNIOTIC TWINS WITH STAGE IIIR TWIN TO TWIN TRANSFUSION SYNDROME. SHE UNDERWENT LASER PHOTOCOAGULATION OF VASCULAR ANASTOMOSIS ON (B)(6) 2022. THE DAY OF THE SURGERY, ONE FETAL SURGEON HAD A SYNCOPAL EPISODE WHICH RESULTED IN COLLAPSING PARTIALLY ON THE PATIENT AND HAD TO BE CARRIED OUT ON A STRETCHER. THE OTHER FETAL SURGEON ENDED UP COMPLETING THE CASE. THE CASE REQUIRED A 1 LITER LACTATED RINGERS AMNIO EXCHANGE OF THE FLUID TO CLEAR UP THE AMNIOTIC FLUID FOR BETTER CLARITY. ULTIMATELY THE SURGERY WAS COMPLETED TO SATISFACTION. ON POD#1 THE ULTRASOUND SHOWED IMPROVEMENT OF THE TWIN-TO-TWIN TRANSFUSION WITH NORMAL DOPPLERS INCLUDING UMBILICAL ARTERY, UMBILICAL VEIN, DUCTUS VENOSUS AND MIDDLE CEREBRAL ARTERY. THERE WAS SOME CHORIOAMNIOTIC SEPARATION FROM THE INSERTION SITE. SHE WAS SENT HOME IN GOOD AND STABLE CONDITION AFTER COMPLETING 24 HOURS OF POST-OPERATIVE ANTIBIOTICS OF ANCEF. ON POD#3 SHE RETURNED TO CLINIC FOR FOLLOW UP ULTRASOUND. SHE REPORTED CRAMPING THROUGH THE WEEKEND BUT WAS TOLERABLE. SHE WAS FOUND TO HAVE AN OPEN CERVIX WITH VERY ECHOGENIC AMNIOTIC FLUID. THE SPECULUM EXAM WAS CONSISTENT WITH DILATED CERVIX AND FETAL MEMBRANES PROTRUDING OUT. SHE HAD UTERINE CONTRACTIONS FOLLOWED BY PREMATURE PRETERM RUPTURE OF MEMBRANES. SHE WAS DIAGNOSED WITH CHORIOAMNIOTIS AND ULTIMATELY HAD TO DELIVER RESULTING IN DUAL FETAL DEMISE. MOTHER HAD A SYSTEMIC INFECTION REQUIRING IV ANTIBIOTICS. SHE HAD RECOVERED. THE ACTUAL LASER PORTION OF THE CASE USING STORZ FETOSCOPIC EQUIPMENT WAS FINE. THERE WERE NO COMPLICATIONS. THE COOK CANNULA/TROCAR WAS ACCIDENTALLY REMOVED DURING THE INITIAL PART OF THE CASE. AFTER THAT THE SURGEON FAINTED. THE CO-SURGEON RESUMED THE CASE HAD TO REGAIN ACCESS AND ENTRY INTO THE UTERUS ANOTHER TWO TIMES. THE FIRST WAS DUE TO THE FETOSCOPE NOT FITTING INTO THE 10FRENCH CANNULA/TROCAR AND THE CANNULA/TROCAR HAD TO BE UPSIZED TO A 12 FRENCH. FDA SAFETY REPORT ID # (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2002961 KARL STORZ AMNIOSCOPE, TRANSABDOMINAL (FETOSCOPE) (AND ACCESSORIES) HFA KARL STORZ SE&CO. KG / KARL STORZ ENDOSCOPY-AMERICA, INC. 11630AA
2002962 KARL STORZ AMNIOSCOPE, TRANSABDOMINAL (FETOSCOPE) (AND ACCESSORIES) HFA KARL STORZ SE&CO. KG / KARL STORZ ENDOSCOPY-AMERICA, INC. 11630KF
2002963 KARL STORZ AMNIOSCOPE, TRANSABDOMINAL (FETOSCOPE) (AND ACCESSORIES) HFA KARL STORZ SE&CO. KG / KARL STORZ ENDOSCOPY-AMERICA, INC. 26008AA

Patients

Seq Age Sex Outcome Treatment
1 76 YR Female Other| D