MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SHEATH FOR RIGID ENDOSCOPE; FIXED INNER SHEATH

Model Number 26040XA

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 07/29/2022

Event Type  Injury  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.

Event Description

Manufacturer incident report (b)(4) received from the factory in germany: it was reported that there was an issue with the product 26040xa - inner sheath, fixed, for 26040sl.According to the complaint description received by the customer, the inner sheath of a hysteroscope 26040xa was disassembled during surgery and the ceramic terminal fell inside the uterus.This happened during operative hysteroscopy.The incident caused a prolongation of the intervention by 4 hours (which normally lasts 15 minutes) resulting in the precautionary hospitalization of the patient.

Manufacturer Narrative

Section b2 and b5 was updated with additional information.The corresponding manufacturer's complaint reference number for this case is (b)(4).

Event Description

The doctor recognized the detachment of the ceramic at the distal part of the inner sheath.It fitted into the right uterine hemi-cavity.The doctor proceeded to attempt to remove it with an equatorial loop but without benefit.Several further attempts had been made to remove the broken part with forceps but without success.A monopolar hysteroscope was introduced to proceed to partial metroplasty to create a larger space and allow the removal of the piece.The piece was finally removed.Internal vigilance reference number for this case is (b)(4).

Manufacturer Narrative

The affected device was returned to the manufacturer on 2022-10-14 for investigation.Visual examination of the affected device revealed that the ceramic beak of the device detached from the shaft.Since the article is already 13 years old and the marking is also difficult to read and almost completely washed out, many reprocessing cycles can be assumed.Due to the high number of reprocessing cycles and chemicals used, the adhesive that attaches the ceramic beak to the shaft has most likely come loose.The device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications.The instruction for the use of this device points out the limitation of reprocessing and a preliminary check of the device especially the ceramic beak before usage.

Event Description

Internal karl storz reference number: (b)(4).

• Brand Name: SHEATH FOR RIGID ENDOSCOPE
• Type of Device: FIXED INNER 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: 15439600
• MDR Text Key: 300071876
• Report Number: 9610617-2022-00269
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551092057
• UDI-Public: 4048551092057
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26040XA
• Device Catalogue Number: 26040XA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization; Required Intervention
• Patient Sex: Female