MAUDE Adverse Event Report: KARL STORZ SE & CO. KG LOW PRESURE TUBE FOR CO2; LOW PRESURE TUBE CENTRAL CO2 GAS SUPPLY ,600CM

Model Number UI003

Device Problems Mechanical Problem (1384); Failure to Align (2522); Connection Problem (2900); Compatibility Problem (2960); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Therapeutic Effects, Unexpected (2099); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Per the factory in (b)(4) evaluation, it is confirmed that in normal condition the plug is not locked in place to the o2 gas supply socket.Under special conditions e.G.If the plug is put angular into the socket and wedged into the socket, a gas flow is possible.The tube is not intended to be put into the o2 gas supply and is correctly labeled as co2.

Event Description

Per the factory in (b)(4), allegedly there was an event occurred in (b)(6) that the customer accidently connected the hose to the central gas line of o2 instead of co2 while using the insufflator.The patient's abdomen was insufflated with o2.The event was noticed and the patient's abdomen was flushed with co2.Procedure was completed with no further intervention.Whether there are complications with patients with o2 instead of co2 insufflated it is currently not known whether the patient would experience any complications, further information is still missing.

Manufacturer Narrative

Correction was made to update h6 codes.

• Brand Name: LOW PRESURE TUBE FOR CO2
• Type of Device: LOW PRESURE TUBE CENTRAL CO2 GAS SUPPLY ,600CM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm,
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm,
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, ca ; 2188201
• MDR Report Key: 9734080
• MDR Text Key: 199989078
• Report Number: 9610617-2020-00027
• Device Sequence Number: 1
• Product Code: NKC
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UI003
• Device Catalogue Number: UI003
• Device Lot Number: PR01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2020
• Initial Date FDA Received: 02/20/2020
• Supplement Dates Manufacturer Received: 01/31/2020
• Supplement Dates FDA Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention