MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HAMOU ENDOMAT SCB

Model Number 26331120-1

Device Problem Activation Problem (4042)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 22-0074 corrective action 6.The described failure condition "device goes to safety state after attaching cassette tubing set" could be confirmed.The tubing cassette was not acknowledged by the device.The unit was disassembled and cleaned the cartridge recalibrated.The complaint records have been analyzed according to the failure description for similar cases.No similar case in relation to a consumption of 2.023 units was found.So it is considered as single fault.The event is filed under internal karl storz complaint id ((b)(4)).

Event Description

It was reported that there was event with a hamou endomat scb.According to the information received the device stops during worktime and doesn't boot after restart.Information about patients health was not provided.Additional patient information is not available.Date of event not known.

• Brand Name: HAMOU ENDOMAT SCB
• Type of Device: HAMOU ENDOMAT 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: 17290668
• MDR Text Key: 318709003
• Report Number: 9610617-2023-00822
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K936231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26331120-1
• Device Catalogue Number: 26331120-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2020
• Initial Date FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2018
• 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