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

Model Number 26331020-1

Device Problem Insufficient Information (3190)

Patient Problem Loss of consciousness (2418)

Event Type  Injury  

Event Description

It was reported that there was an event with a hamou endomat scb.According to the information received on jan.28, 2019, the patient collapsed during surgery and had to be resuscitated.The resuscitation was successful.No information is available on possible consequential damage to the patient.Detailed information has already been requested, but there has been no feedback from the hospital.The event already occured in (b)(6) 2018.No further information available.

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa (b)(4) corrective action 6.Product was sent in for repair before the potential incident was communicated.After described incident the product was not sent in for investigation.The analysis back then found: yellowed tubing.Pressure sensor defect.Following questions were sent to the hospital: what kind of surgery was performed? gynecological laparoscopy.What kind of symptoms did occur? cardiovascular problems.Has the flushing liquid quantity been balanced? not specified.Which failure code was indicated by the pump? none.With the information received the repair seems not to be related to the occurred event.As, per information received, no failure code was displayed, a malfunction of the device can be excluded.The complaint database was analysed, no further complaints with similar failure description were found.A tur syndrome is suspected, but could not be confirmed.The event is filed under internal karl storz complaint id ((b)(4)).

• Brand Name: ENDOMAT SCB N. HAMOU
• Type of Device: ENDOMAT SCB N. HAMOU
• 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: 17418282
• MDR Text Key: 320022316
• Report Number: 9610617-2023-00826
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K936231
• 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: 07/24/2023

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: 26331020-1
• Device Catalogue Number: 26331020-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2019
• Initial Date FDA Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/27/2018
• 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): Life Threatening