MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CO2 HIGH PRESSURE TUBE, PIN-INDEX; HIGH-PRESSURE MEDICAL GAS HOSE

Model Number	20400028
Medical Device Problem Codes	Leak/Splash (1354); Device Handling Problem (3265)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/17/2024
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 the co2 high pressure tube has leaked.The grey cable looked frozen where the leak had come out.The veterinary procedure was aborted.No information about the aborted procedure available.Due to the information about the aborted procedure.
Additional Manufacturer Narrative
Additional information was received for event date in b3 and b5 for description summary.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
Additional information: routine lap spay: placed the two ports, suspended the r ovarie, partially cauterised the plexus and got to cutting off the uterine horn off.No concerns with gas up until this point, then encountered issues with the gas cylinder, popping sound heard once only, then hissing sound- multiple staff members tried to fix it.Changed gas cylinder but problem continued to present itself.Procedure aborted, patient well on recovery.Operation continued on the 30th after it had been fixed.
Additional Manufacturer Narrative
Additional information was added for d4 lot number zp01 and d9 product was returned on december 11,2024.No changes regarding the investigation results the event is filed under internal karl storz complaint id:(b)(4).
Additional Manufacturer Narrative
The product was not returned to karl storz tuttlingen.It was tested on site by a service technician.The investigation of the product was completed on 2024-nov-29.The hose connection was tested and reported fault could be confirmed.The washer found to be compressed and requiring replacement.A spare washer was still attached to the hose.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CO2 HIGH PRESSURE TUBE, PIN-INDEX
• Common Device Name: HIGH-PRESSURE MEDICAL GAS HOSE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr,-kark - storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr,-kark - storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 20605341
• Report Number: 9610617-2024-00435
• Device Sequence Number: 20815575
• Product Code: NKC
• UDI-Device Identifier: 04048551067574
• UDI-Public: 04048551067574
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/20/2024

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: 20400028
• Device Catalogue Number: 20400028
• Device Lot Number: ZP01
• 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: 10/18/2024
• Supplement Date Received by Manufacturer: 11/06/2024; 11/29/2024; 12/11/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 11/19/2024; 12/13/2024; 12/20/2024
• 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
• Patient Sex: Unknown