MAUDE Adverse Event Report: KARL STORZ SE & CO. KG WORKING ELEMENT; RIGID ENDOSCOPE WORKING GUIDE

Model Number 26050E

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 01/11/2023

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

It was reported that the patient had burns on the introitus vaginae (vestibulum) and an additional medical intervention was required.Additional patient information is not available.

Manufacturer Narrative

Examination of the items revealed normal signs of use and wear.No product defect was found that could have caused the burn.It is not known at what time the burns were discovered.Tissue burns may occur during coagulation.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: WORKING ELEMENT
• Type of Device: RIGID ENDOSCOPE WORKING GUIDE
• 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: 16486666
• MDR Text Key: 310709915
• Report Number: 9610617-2023-00052
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551092293
• UDI-Public: 4048551092293
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26050E
• Device Catalogue Number: 26050E
• Device Lot Number: NP01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2023
• 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
• Treatment: ZC_200948426: MATERIAL-NO: 26050NK, LOT-NO: P001.; ZC_200948441: MATERIAL-NO: 26050NK, LOT-NO: Z001.; ZC_200948444: MATERIAL-NO: 277, LOT.NO: RQ01.
• Patient Outcome(s): Required Intervention