MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOMAT N. HAMOU SCB; SURGICAL IRRIGATION/SUCTION SYSTEM

Model Number 26331120-1

Device Problem Ambient Noise Problem (2877)

Patient Problem Insufficient Information (4580)

Event Date 07/04/2022

Event Type  Injury  

Event Description

As per manufacturer incident report # (b)(4) we received from the factory in germany: during procedure, the endomat emitted an important noise that led the operators to turn it off as a precautionary measure.The device was replaced with a system consisting of a bag press and a vacuum cable to be connected directly to the vacuum of the operating room.According to the customer's information, the non-use of the endomat caused a "considerable lengthening" of surgical time.

Manufacturer Narrative

The affected device was requested for return.The investigation is pending.After receiving the affected unit, an investigation on the returned product will be performed by a designated karl storz employee.

Manufacturer Narrative

The claimed item was returned on 2022-08-01.Based on the evaluation results (dated 2022-09-08), the device is able to work as per factory specifications.A test for 12 hours with the maximal flow could not provoke the reported noise.Based on the log file analysis, the failure could not be traced back to a setting error nor a human error.In conclusion, the reported malfunction could not be confirmed.

• Brand Name: ENDOMAT N. HAMOU SCB
• Type of Device: SURGICAL IRRIGATION/SUCTION SYSTEM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: anja fair ; 13803 n. promenade blvd.; stafford, TX 77477
• MDR Report Key: 15069125
• MDR Text Key: 296267701
• Report Number: 9610617-2022-00126
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K936231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 26331120-1
• Device Catalogue Number: 26331120-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2022
• Initial Date FDA Received: 07/20/2022
• Supplement Dates Manufacturer Received: 09/08/2022
• Supplement Dates FDA Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other