MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ELECTRONIC CO2 ENDOFLATOR SCB

Model Number 26430520-1

Device Problem No Device Output (1435)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that an endoflator stopped working mid case.No further information available.

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 22-0074 corrective action 12.As investigated the high pressure regulator, flow sensors and inner tubes were checked for contamination.It was observed that the high pressure regulator is contaminated with a build-up of particulate.The device was manufactured in january 2014.Due to the age of the device the contamination is most probably a build up of particulate from dirty gas bottles or the gas tubes.The root cause of failure most likely is the contamination present and therefore associated with the user's environmental conditions.No indication for a manufacturing issue were found during the investigation.The event is filed under internal karl storz complaint id (b)(4).

• Brand Name: ELECTRONIC CO2 ENDOFLATOR SCB
• Type of Device: ELECTRONIC CO2 ENDOFLATOR SCB
• 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: 17039085
• MDR Text Key: 317444370
• Report Number: 9610617-2023-00806
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K962030
• 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: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26430520-1
• Device Catalogue Number: 26430520-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1