MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CYLINDER HOSE WITH SWITCH-OVER VALVE (PIN-INDEX)

Model Number MAJ-1985

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 04/14/2021

Event Type  Injury  

Manufacturer Narrative

The subject device was returned to omsc for evaluation.Omsc checked the subject device and found that the packing (o-ring) was removed, but there was no abnormality on the exterior.The investigation is in progress at this time.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user facility that during the preparation for the laparoscopic procedure with the subject device, it was found that co2 gas was leaking from the co2 insufflation connector of the high flow insufflation unit uhi-4, and a nurse touched the subject device (cylinder hose with switch-over valve) with her bare hands and suffered a low-temperature burn.In addition, according to the information obtained from the user, the burned area was red on the day of this event, but the next day the burned area was blistered and swollen.The degree of the reported burn was "superficial dermal burn".To treat the burn, the blister was drained, and ointment was applied twice a day.The facility checked the co2 gas leaking point and found that the packing had been detached from the subject device and had fallen off on the floor.There was no report of further patient injury associated with this event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was returned to olympus medical systems corp.(omsc).Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Based upon the reported information and the investigation results, omsc concluded that the reported event was attributed to the subject device being used with the packing (o-ring) detached.The exact cause of the packing detachment could not be conclusively determined, but there was possibility that this detachment was attributed to a mistake in the mounting method or improper mounting by the user, because the o-ring lock nut which fixed the packing (o-ring) had scratches.If additional information is received, this report will be supplemented.

• Brand Name: CYLINDER HOSE WITH SWITCH-OVER VALVE (PIN-INDEX)
• Type of Device: CYLINDER HOSE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11796971
• MDR Text Key: 249718529
• Report Number: 8010047-2021-06085
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K110294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/09/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: MAJ-1985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/16/2021
• Initial Date FDA Received: 05/10/2021
• Supplement Dates Manufacturer Received: 05/17/2021
• Supplement Dates FDA Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other