MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION OES CYSTONEPHROFIBERSCOPE; CYSTOSCOPE

Model Number CYF-5A

Device Problems Hole In Material (1293); Peeled/Delaminated (1454)

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

Event Date 03/30/2011

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report was returned to omsc for evaluation.The evaluation confirmed that the bending section rubber of the subject device was partially torn and missing and there was a hole in the bending section rubber.There was a scratch in the bending section rubber and crack in the glue of the bending section.Omsc reviewed the manufacture history of the subject device and confirmed no irregularity.The cause of the missing of the bending section could not be determined, but a strong physical stress may cause the damage.The operation manual has already warns "before each case, prepare and inspect this instrument as instructed below.Inspect other equipment to be 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 10,".

Event Description

Olympus medical systems corp.(omsc) performed a mdr retrospective review and found that this report was required.Omsc was informed that after a cystoscopy, the facility noticed that the bending section rubber of the subject device was partially missing and the metal mesh blade covered by the rubber was exposed.The facility reported that they did not know when and where the bending section rubber torn.There was no patient injury reported related to this event.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nisihina ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-057 ; JA 192-8057 ; 42 642 517
• MDR Report Key: 6281946
• MDR Text Key: 65897793
• Report Number: 8010047-2017-01071
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/27/2017

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: No Information
• Device Model Number: CYF-5A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/30/2011
• Initial Date FDA Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2006
• 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