NA 11630KFRecalls & reported problems
Karl Storz GmbH & Co. KG · Operating Sheath, 9 Fr. · Class f
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048551051993), received between Nov 22, 2022 and Nov 22, 2022 — classified as 1 death.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Abdominal Cramps1
- Chorioamnionitis1
- Rupture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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
Patient problems: Abdominal Cramps; Chorioamnionitis; Rupture
MAUDE report 15847620 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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