MAUDE Adverse Event Report: KARL STORZ SE & CO. KG OPERATING SHEATH, 9 FR.; RIGID ENDOSCOPE SHEATH, REUSABLE

Model Number 11630KF

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/07/2022

Event Type  Death  

Manufacturer Narrative

The product involved was not returned for evaluation.Based on this received information it is concluded that the involved karl storz products did not malfunction and did not cause or contribute to the reported event.This event is filed under internal complaint id (b)(4).

Event Description

As per medwatch mw5112794 received via email from the fda: "patient 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 [[?]].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 chorioamniotic 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 10-french cannula/trocar and the cannula/trocar had to be upsized to a 12 french." further information received by the physician who reported this event: "i can confirm that there was no issues with the equipment.Everything from the technical standpoint of the surgery was fine." the event involved a 11630kf operating sheath, a 11630aa miniature straight forward telescope, and a 26008aa hopkins straight forward telescope.

• Brand Name: OPERATING SHEATH, 9 FR.
• Type of Device: RIGID ENDOSCOPE SHEATH, REUSABLE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 15847620
• MDR Text Key: 304167365
• Report Number: 9610617-2022-00314
• Device Sequence Number: 1
• Product Code: HFA
• UDI-Device Identifier: 04048551051993
• UDI-Public: 4048551051993
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H040005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11630KF
• Device Catalogue Number: 11630KF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 11630AA MINIATURE STRAIGHT FORWARD TELESCOPE.; 26008AA HOPKINS STRAIGHT FORWARD TELESCOPE.
• Patient Outcome(s): Other; Death
• Patient Sex: Female