MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH F. RESECT. SHEATH, 15 FR.; ENDOSCOPE ELEMENT, SHEATH

Model Number 26053CB

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

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).

Event Description

The event occurred in italy.It has been reported that the ceramic tip of an inner sheath is damaged.According to the distributor who reported the problem, it is unclear whether the problem occurred during sterilization or during surgery.No further information is available beyond this.No negative impact on the state of health was reported.The error description does not provide information on whether ceramic fragments remained in the patient's body or not.

Manufacturer Narrative

The investigation revealed that the reason for for the breakage is a user error.On the one hand, the reason is improper handling, the item must be checked for damage before each use, in addition, the heat effect of the burnt loop may also have caused the ceramic to break.On the other hand, the material may have caused material fatigue due to its advanced age and the resulting number of reprocessing cycles.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: INNER SHEATH F. RESECT. SHEATH, 15 FR.
• Type of Device: ENDOSCOPE ELEMENT, SHEATH
• 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 90245-5017 ; 4242188738
• MDR Report Key: 16437113
• MDR Text Key: 310167346
• Report Number: 9610617-2023-00045
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26053CB
• Device Catalogue Number: 26053CB
• Device Lot Number: VN01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2022
• 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): Other