MAUDE Adverse Event Report: KARL STORZ SE&CO. KG / KARL STORZ ENDOSCOPY-AMERICA, INC. KARL STORZ; AMNIOSCOPE, TRANSABDOMINAL (FETOSCOPE) (AND ACCESSORIES)

Model Number 11630KF

Device Problem Difficult or Delayed Activation (2577)

Patient Problems Chorioamnionitis (1777); Rupture (2208); Abdominal Cramps (2543)

Event Date 10/07/2022

Event Type  Death  

Event Description

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).

• Brand Name: KARL STORZ
• Type of Device: AMNIOSCOPE, TRANSABDOMINAL (FETOSCOPE) (AND ACCESSORIES)
• Manufacturer (Section D): KARL STORZ SE&CO. KG / KARL STORZ ENDOSCOPY-AMERICA, INC.
• MDR Report Key: 15658951
• MDR Text Key: 302277661
• Report Number: MW5112794
• Device Sequence Number: 2
• Product Code: HFA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/20/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 11630KF
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Death
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White