MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOMAT SELECT

Model Number	UP210
Medical Device Problem Codes	Material Puncture/Hole (1504); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the "user is experiencing some air bubbles" during procedure.No negative impact in state of health reported.
Additional Manufacturer Narrative
Concomitant products added to d10.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Leading product: article: up210, sn: (b)(6).Location of device: at manufacturer.Product returned on: 2025-07-16.Concomitant product: article: up008, sn: (b)(6), location of device: at manufacturer, product returned on: 2025-07-16.The device 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).
Additional Manufacturer Narrative
Device evaluation: the device up210 and up008 were sent to the manufacturer for inspection.During the manufacturer's technical inspection, the error description provided by the customer, "user is experiencing some air bubbles" could be confirmed and assigned to product up008.The pressure diaphragm of up008 was mechanically damaged, which meant that it was no longer leak-proof and air was able to enter the hose system.This has led to the bubble formation described by the customer.The defects found on the up210 are independent from the reported issue.The leaflet of up008 is stating a required performance of the leakage test clearly in the warning section.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ENDOMAT SELECT
• Common Device Name: ENDOMAT SELECT
• 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: 21931271
• Report Number: 9610617-2025-00728
• Device Sequence Number: 8650764
• Product Code: HIG
• UDI-Device Identifier: 04048551376041
• UDI-Public: 04048551376041
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K180735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/10/2025

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
• Operator of Device: Health Professional
• Device Model Number: UP210
• Device Catalogue Number: UP210
• Device Lot Number: YO06500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2025
• Supplement Date Received by Manufacturer: 04/15/2025; 07/16/2025; 10/09/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 05/19/2025; 08/19/2025; 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICLE: 26120BA, SN: (B)(6); ARTICLE: 26153BI, LOT: YO07.; ARTICLE: 26153BO, LOT: ZO01.; ARTICLE: UP008, SN: (B)(6); ARTICLE: UP602, LOT: SOFTWARE HENCE, NO SN OR LOT.
• Patient Sex: Unknown