MAUDE Adverse Event Report: KARL STORZ SE & CO. KG RIGID ENDOSCOPE WORKING GUIDE; WORKING ELEMENT, BIPOLAR

Model Number 27040DB

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/25/2023

Event Type  Injury  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported that there was an issue with a working element.There is no failure description available.According to the information received there was an additional medical intervention necessary due to the incident reported and a poor haemostasis occurred.Due to limited information and the information mentioned above this case was rated deemed reportable.Additional information was already requested.If additional information becomes available this report will be updated unsolicited.

• Brand Name: RIGID ENDOSCOPE WORKING GUIDE
• Type of Device: WORKING ELEMENT, BIPOLAR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 17738496
• MDR Text Key: 323310679
• Report Number: 2020550-2023-00255
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04048551075500
• UDI-Public: 4048551075500
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 27040DB
• Device Catalogue Number: 27040DB
• Device Lot Number: XR114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other