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

Model Number 26331120-1

Device Problem Improper Flow or Infusion (2954)

Patient Problem Respiratory Acidosis (2482)

Event Date 12/21/2021

Event Type  Injury  

Manufacturer Narrative

According to a trend analysis, 2 similar complaints were found.In conclusion, the reported malfunction is no systemic issue.Further preliminary results are currently not available.After receiving the affected unit, an investigation will be performed by a designated karl storz employee.

Event Description

As per manufacturer incident report (b)(4) we received from the factory in (b)(6): during hysteroscopy-resection of a 4 cm type 2-3 fibroid, a desaturation in conjunction with a hypocapnia was reported.A further treatment was performed to exclude a gas embolism, but a pneumoperitoneum was found.A laparoscopy to eliminate uterine perforation or digestive wound.

Manufacturer Narrative

The device was evaluated on 2022-05-23.According to the visual inspection, only cosmetical damages could be found.Based on the log file analysis, the device was not started at the date of event.We conclude that the event occurred on 2022-04-12.No error message could be found.Upon next start up after 2022-04-12, the real time clock as well as the settings were reset, because the battery cell has come loose from its holder.This was probably caused by a mechanical shock.Based on the risk file, the most probable root cause is a user error, because the pressure was set to high.

Manufacturer Narrative

The device was evaluated on 2022-05-23.According to the visual inspection, only cosmetical damages could be found.No error message could be found.Upon next start up after 2022-04-12, the real time clock as well as the settings were reset, because the battery cell has come loose from its holder.This was probably caused by a mechanical shock.Based on the risk file, the most probable root cause is a user error, because the pressure was set too high.

• Brand Name: ENDOMAT N. HAMOU SCB
• Type of Device: SURGICAL SUCTION / RINSING 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 ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 14283140
• MDR Text Key: 290914079
• Report Number: 9610617-2022-00056
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• 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: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Sex: Female