MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION ULTRASONIC GASTROVIDEOSCOPE

Model Number GF-UC140-P-AL5

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2014

Event Type  malfunction  

Event Description

Olympus medical system corp.(omsc) was informed that during diagnostic procedure for a suspect of pancreatic lesion, thorax tac (truncus arteriosus communis) revealed the presence of bubbles.The procedure was completed with the subject scope.The patient was transferred to another hospital and prolonged hospitalization for one day.There was no patient harm reported without this event.

Manufacturer Narrative

The subject device was returned to omsc for evaluation.Based on the investigation there was no defect or malfunction of the channels.The air/water (a/w) nozzle unit was clogged and had a trace of being deformed several times.The sharp edges at the nozzle unit wee caused by mechanical force.It was assumed that foreign material clogged in the a/w nozzle channel, and when the customer removed the foreign material, the a/w nozzle unit was damaged.The occured damages indicated that mechanical force and/or unsuited handling of the item must have been applied.Furthermore the cementing around the cover of bending section was loosened and leaky.Additionally the light guide (lg) lens and ccd lends were cracked by shock or drop.The glue around the lg lens is porous and broken, most probably caused by chemical attack.The ultrasonic cord and universal cord that connected the operation unit and lg were kinked and buckled several times.Even we found signs of humidity inside the ultrasonic connector.The surface of the probe unit was heavily scratched.The manufacturing history was reviewed, with no irregularities related to this problem noted.If additional information is available at a later time, this report will be supplemented.

Manufacturer Narrative

This is a supplemental report for mfr report #8010047-2014-00557.Olympus medical systems corporation (omsc) performed a mdr retrospective review and found that this supplemental report is required on december 24, 2015.The subject device was returned to the sales department of olympus in (b)(4) and (b)(4) evaluated the subject device.The subject device was not returned to omsc.The conclusion of this issue is no different from the initial report.This report is being submitted as a medical device report in an abundance of caution.

• Brand Name: ULTRASONIC GASTROVIDEOSCOPE
• Type of Device: ULTRASONIC GASTROVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi 192-8 507; JA 192-8507
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 4272372
• MDR Text Key: 21174974
• Report Number: 8010047-2014-00557
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/08/2016

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
• Device Operator: Health Professional
• Device Model Number: GF-UC140-P-AL5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2014
• Initial Date FDA Received: 10/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2002
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention