MAUDE Adverse Event Report: OLYMPUS; CO-2 SOURCE ADAPTER

Model Number K10037009

Device Problems Loss of or Failure to Bond (1068); Leak/Splash (1354); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2023

Event Type  malfunction  

Event Description

We are doing a trial of olympus disposable tubing.A leak occasionally occurs between the disposable bottle and the disposable cap despite multiple attempts at getting the cap to seat on the bottle tightly.This renders lens wash inoperable.This also renders co2 insufflation inoperable.This equipment should be a "never fail" type of equipment.To finish this case, the endoscopy tech had to hold the on the bottle for the remainder of the case.Who: olympus disposable tubing malfunction during emergent case.Why: new disposable tubing is difficult to retain a good seal.How: representative from steris is in-house today assisting with trialing a different disposable tubing system that may be easier to achieve and retain a seal.Outcome: no harm done to patient, will continue to trial tubing until the safest and most efficient tubing is chosen, for best patient outcome.Endoscopy manager, had the olympus service rep do a second in-service on the olympus tubing and barxx water bottle setup.Issues continued intermittently with the olympus tubing post in-service.Endoscopy manager notified the olympus service rep that the issues with the tubing were ongoing after the second in-service.Olympus tubing trial was ended.Other tubing vendors will be contacted for tubing options.Outcome: moving forward, olympus tubing trial was discontinued.Other tubing vendors will be consulted with.No harm was done to the patient.

• Type of Device: CO-2 SOURCE ADAPTER
• Manufacturer (Section D): OLYMPUS; 5325 hellyer ave.; san jose CA 95138
• MDR Report Key: 16764207
• MDR Text Key: 313534121
• Report Number: 16764207
• Device Sequence Number: 1
• Product Code: NKC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: K10037009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/07/2023
• Event Location: Other
• Date Report to Manufacturer: 04/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 32485 DA
• Patient Sex: Male
• Patient Race: White