MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ANATOMICAL BLADE, LONG

Model Number 26168DL

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Internal Organ Perforation (1987)

Event Date 05/26/2023

Event Type  Injury  

Event Description

During the intervention (hysterectomy under celio) in use, the blade broke in utero.This resulted in vaginal sores that had to be sutured.

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).

• Brand Name: ANATOMICAL BLADE, LONG
• Type of Device: ANATOMICAL BLADE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 17136058
• MDR Text Key: 317248902
• Report Number: 2020550-2023-00131
• Device Sequence Number: 1
• Product Code: MDM
• 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: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26168DL
• Device Catalogue Number: 26168DL
• Device Lot Number: LE02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/14/2023
• Device Age: 18 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other