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 07/13/2022

Event Type  Injury  

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.

Event Description

As per manufacturer incident report #(b)(4) we received from the factory in germany: after switching on the endomat in the or preparation room, an "explosion" and smoke development occurred on the instrument.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 times.

Event Description

Internal complaint number: (b)(4).

Manufacturer Narrative

The evaluation has been finished on 2022-09-22.The battery is not in the battery holder anymore but jammed between two pcbs on the front panel.It must have created a short cut, which resulted in the battery exploding as soon as the device was connected to mains and switched on.The battery may have felt out of the battery holder due to a strong mechanical impulse, maybe due to the device falling on the ground.There is a damage on the rear top back side that is an indicator of such a fall.

• 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: 15138847
• MDR Text Key: 296971935
• Report Number: 9610617-2022-00134
• 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: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2021
• 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