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

Model Number 26168DL

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem Internal Organ Perforation (1987)

Event Date 05/26/2023

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

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

Based in the investigation results it is possible to conclude that the user has behaved incorrectly.There are signs of use at the distal end (indentations/notches).The ceramic attachment can be damaged by improper handling (e.G.Levering, knocks) in combination with the age of 18 years, resulting in breakage.The event is filed under internal karl storz complaint id: (b)(4).

Manufacturer Narrative

The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.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
• 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: 17136056
• MDR Text Key: 317245468
• Report Number: 9610617-2023-00131
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/14/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization