MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION OES CHOLEDOCHOFIBERSCOPE

Model Number CHF-CB30S

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus medical systems corp.(omsc) for evaluation but was returned to olympus winter and ibe.The evaluation confirmed that the coating of the insertion portion tore near the proximal end of the angulation rubber and the coating was partially missing.The evaluation also confirmed the metal mesh under the coating was exposed at the damaged insertion portion.Since the insertion damage was likely caused by inappropriate handling of grasping forceps, olympus contacted the facility to obtain the information about the grasping forceps but without success.Olympus reviewed the service and manufacturing record of the subject device.The review confirmed the subject device was manufactured on (b(6) 2011 and got parts replacement at the insertion portion in (b)(6) 2015.There was no irregular in the service and manufacturing record.The instruction manual has already warned " never insert or withdraw the endoscope's insertion tube while the up/down angulation lock is fixed.Patient injury or equipment damage can result."," do not manipulate the flexible tube of the endoscope with any grasping forceps other than the grasping forceps 5 mm o.D.T1079.Insertion portion damage can occur.".

Event Description

Olympus was informed that after a laparoscopic cholecystectomy procedure, the facility noticed that the coating of the insertion portion of the subject device cracked, and the metal part under the coating was exposed and contaminated with blood and body fluid.The subject device was reportedly used with an unknown single-use trocar during the procedure.It was also reported that the chf-cb30s had been reprocessed with olympus washer disinfector etd3 using peracetic acid and sterilized with non-olympus sterilizer (sterrad 100s).There was no report of patient injury associated with this event.

• Brand Name: OES CHOLEDOCHOFIBERSCOPE
• Type of Device: CHOLEDOCHOFIBERSCOPE
• 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
• MDR Report Key: 5784820
• MDR Text Key: 49243121
• Report Number: 8010047-2016-00933
• Device Sequence Number: 1
• Product Code: FBN
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 07/12/2016

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: CHF-CB30S
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/20/2016
• Initial Date FDA Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2011
• 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