MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH, FOR 27040 SD/SL

Model Number 27040XA

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2021

Event Type  malfunction  

Manufacturer Narrative

The previous reportability decision for this event was reversed based on a retrospective review.In complaint (b)(4) it was reported that the tip broke off in a patient.It was reported that the inner shaft with a ceramic insulated beak had broken inside a patient.The similar complaint was filed because it was not clear whether pieces remained in the body of the patient.The affected device has been requested for investigation by the manufacturer.Device was not returned for investigation.Internal karl storz reference number: (b)(4).

Event Description

It was reported that the tip of the inner sheath or a piece of the insulated beak broke/shattered off during a procedure and fell into the patient.The pieces were completely retrieved, and no harm occurred to the patient.

• Brand Name: INNER SHEATH, FOR 27040 SD/SL
• Type of Device: 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
• MDR Report Key: 17971366
• MDR Text Key: 326198021
• Report Number: 9610617-2023-00304
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551076521
• UDI-Public: 4048551076521
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221893
• 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
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27040XA
• Device Catalogue Number: 27040XA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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