MAUDE Adverse Event Report: MEDLINE INDUSTRUIES LP; ENDO KIT

Catalog Number	DYKE1649A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the valves were inserted into the scope as usual with no deviation from the usual procedure.Before the procedures started the scope was tested for flushing air/co2 insufflation.Everything was working appropriately until insertion of the scope into the patient.After insertion the scope was leaking/splattering with water via the valves.The clinician was not able to put air/co2 into the patient to see the lumen.According to the reporter the scope was withdrawn, the valves were changed to a different brand and the scope was checked again with no deficiencies noted.The procedure was completed without further incident or delay.The sample was not returned to the manufacturer for evaluation.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the valves were leaking and the clinician could not insufflate using co2 when doing a procedure.
Additional Manufacturer Narrative
Sample received 11/5/2021: the customer returned a case of unused samples and a biohazard bag containing several used valves.During evaluation of all of the received samples there was no observed physical damage to any of the unused valves or their vendor packaging.In the used components, we observed no damage to the exterior of the valves and no noticeable damage to the connection ends.This item is a pre-sealed component in a kit.The information in this report and the sample have been forwarded to the component manufacturer for further evaluation.The root cause could not be determined at this time.No additional information is available.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: ENDO KIT
• Manufacturer (Section D): MEDLINE INDUSTRUIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 12737499
• Report Number: 1423395-2021-00056
• Device Sequence Number: 14592602
• Product Code: NWR
• UDI-Device Identifier: 10193489375152
• UDI-Public: 10193489375152
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2021

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYKE1649A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown