MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOFLATOR 40

Model Number UI400

Device Problem Gas Output Problem (1266)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Belated evaluation and reporting of this complaint, was done during retrospective review as part of capa 22-0074 corrective action 12.The described failure could not be reproduced.Endurance test executed.Device tested according to protocol, safety check performed.No root cause assignable.The event is filed under internal karl storz complaint id ((b)(4)).

Event Description

Insufficient compensating flow rate when pressure decreases.Impossible to aspirate into the peritoneal cavity without losing the entire pneumoperitoneum.Impossible to open a chimney through a trocar to reduce the fumes.Increased operating time.No further information available.

• Brand Name: ENDOFLATOR 40
• Type of Device: ENDOFLATOR 40
• 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
• MDR Report Key: 17031029
• MDR Text Key: 316279941
• Report Number: 9610617-2023-00660
• Device Sequence Number: 1
• Product Code: FCX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K161554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UI400
• Device Catalogue Number: UI400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2019
• 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