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

Model Number 11630KH

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

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908)

Event Date 11/18/2023

Event Type  Injury  

Manufacturer Narrative

Reported device would not be returned for evaluation because the physician believed there was no malfunction or no device contribution to the adverse event.Out of abundent for precautions and patient safety, this case will be documented and evaluated.Once the evaluation is complete, a supplemental report would be made to the fda.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported to karl storz that a patient's membrane was ruptured after surgery.The patient was pregnant with twins; however, the patient had twin-to-twin tranfusion syndrome (ttts) stage 3, a rare condition where one twin receives too much blood while the other twin receives too little blood.One twin had reversed blood flow in the umbilical artery, while the other twin had intermittent absent blood flow in the umbilical artery.The difference in growth between the twins was 18%.The patient also had large subchorionic hematoma.The patient underwent fetoscopic laser photocoagulation of placental anastomosis for ttts.The surgery was successful, but there were risks involved, such as membrane separation that could lead to premature rupture of membranes after the surgery and placental abruption.Without receiving fetoscopic laser photocoagulation surgery, the patient was at risk of losing one of both twins.After the surgery, the patient was found to have a significant amount of chorioamniotic separation but remained stable.Later that afternoon, the patient ruptured her membranes but remained stable.The patient was resealed and received latency antibiotics.The twins recovered from surgery with concordant fluid, bladder seen, and normal dopplers.On the 22 week and 1 day, the patient received c-section to deliver the twins because the patient had severe preeclampsia on the days prior.Both twins are in the nicu and stable.It was confirmed by the treating physician that karl storz devices were not malfunctioned and did not contribute to the complication.The physician believed that the complication was due to patient's previous subchorionic hematoma.

Manufacturer Narrative

No product would be returned as the doctor determined that our devices did not contribute to the adverse event, and it was caused by patient's condition.No corrective actions necessary as there is no critical and/or systematic deviation found during investigation.This complaint will continue to be tracked and trended.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: OPERATING SHEATH, 9 FR.
• Type of Device: OPERATING SHEATH, 9 FR.
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave.; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 18619973
• MDR Text Key: 334258958
• Report Number: 9610617-2024-00022
• Device Sequence Number: 1
• Product Code: HFA
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11630KH
• Device Catalogue Number: 11630KH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female