MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS CYSTOVIDEOSCOPE

Model Number CYF-240

Device Problems Break (1069); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2018

Event Type  malfunction  

Manufacturer Narrative

The fragment was not sent to olympus.The subject device in this report has not been returned to omsc for evaluation, but was returned to olympus (b)(4).(b)(4) confirmed the followings during inspecting the subject device.The subject device passed the air leakage testing at (b)(4).The adhesive of one of the two light guide lenses was completely missing.The adhesive of other light guide lenses was deteriorated and partially missing.No other than the above material or components were found to be missing from the subject device.There were cracks and chippings in the light guide lenses.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.Although (b)(4) has not received the fragment itself, it is surmised that the fragment found within the patient bladder was missing adhesive from the light guide lenses.The instruction has already warns and instructs; before each case, prepare and inspect this instrument as instructed below.Inspect other equipment used with this instrument as instructed in their respective instruction manuals.Should the slightest irregularity be suspected, do not use this instrument and see chapter 9, ¿troubleshooting¿.If the irregularity is still suspected after consulting chapter 9, contact olympus.Damage or irregularity may compromise patient or user safety and may result in more-severe equipment damage.If the endoscope is visibly damaged, does not function as expected or is found to have irregularities during the inspection described in chapter 3, ¿preparation and inspection¿, do not use the endoscope.Contact olympus.Some problems that appear to be malfunctions may be correctable by referring to section 9.1, ¿troubleshooting guide¿.If the problem cannot be resolved by the described remedial action, stop using the endoscope and send it to olympus for repair.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that a black plastic fragment fell off from the distal end of the subject device within the patient¿s bladder during an unspecified diagnostic procedure.The procedure was prolonged in order to retrieve the fragment using a stent retriever from the patient.The procedure was completed and the patient was discharged from the user facility on the day the patient underwent the procedure.There was no report of injury associated with this report.

• Brand Name: EVIS CYSTOVIDEOSCOPE
• Type of Device: CYSTOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-sho; hachioji-shi, hachioji-shi 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 8389204
• MDR Text Key: 139439998
• Report Number: 8010047-2019-01183
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K843084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2018
• Initial Date FDA Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2006
• 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