MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TISSUE MORCELLATION SYSTEM; SHAVER BLADE GYN

Model Number 26208SB

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Unintended Radiation Exposure (4565); Insufficient Information (4580)

Event Date 08/09/2023

Event Type  Injury  

Event Description

It was reported that during a polyp resection, the tip of a shaver blade broke and remained in the patient.It was not possible to retrieve the broken piece immediately.Therefore, an x-ray had to be taken and further surgery is planned to have the blade piece removed under general anesthesia.

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).

Manufacturer Narrative

The shaft as well as the fractured tip (cutter) was received on 2023-08-16 at the manufacturing site and was therefore available for investigation.The investigation has been completed on the 2023-11-15.Findings: visual and microscopical examination revealed that the tip of the cutter has broken off and separated from the shaft.The examination of the claimed article 26208sb revealed that the break at the distal end was probably caused by the following factor: excessive force applied to the distal end in combination with microcracks due to a inadequate preparation.There is pitting on the shaft, which weakens the material and can cause microcracks.This may lead to corrosion forming in the material.If an excessive force is now applied to the material coupled with a high speed, these microcracks spread, and a breakage occurs.In addition, it was found that the teeth at the distal end (cutter) are damaged/worn which indicates that a higher force is required during preparation.The device product history records have been checked for the available lot number and found to be according to the specification, valid at the time of production.Based on the available information and the results of the examination, the defect described by the customer can be confirmed.There is no indication for a material-, manufacturing- or design-related failure.The root cause of the reported issue can be traced back to an overload situation.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: TISSUE MORCELLATION SYSTEM
• Type of Device: SHAVER BLADE GYN
• 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: 17606839
• MDR Text Key: 321777781
• Report Number: 9610617-2023-00217
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K223520
• 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
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26208SB
• Device Catalogue Number: 26208SB
• Device Lot Number: UN01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2022
• 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 Age: 41 YR