MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-H260

Device Problems Material Separation (1562); Microbial Contamination of Device (2303); Material Deformation (2976); Material Integrity Problem (2978); Scratched Material (3020)

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

Event Date 12/25/2018

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has been returned to omsc and is under evaluation.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that as a result of multiple microbiological testing by the user facility, microbes were detected three consecutive times from the sample collected from the subject device.The type and the amount of microbes are unknown.The device had been reprocessed with a non-olympus automated endoscope reprocessor, esr-100 (fuji film), using peracetic acid (acecide).There was no report of infection associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to provide the additional information.The detailed result of the microbiological testing by the user facility was as follows.[first time; (b)(6) 2019] klebsiella sp., enterobacter sp., stenotrophomonas maltophilia, yeast-like fungus and glucose-non-fermentative bacteria (11cfu-100cfu).[second time; (b)(6) 2019] klebsiella sp., stenotrophomonas maltophilia and glucose-non-fermentative bacteria (under 10cfu).[third time; (b)(6) 2019] klebsiella sp., enterobacter sp., stenotrophomonas maltophilia, glucose-non-fermentative bacteria, and yeast-like fungus (under 10cfu).The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code" of d2 and "pma/510(k) number" of g5.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Omsc evaluated the subject device and confirmed as follows.The inside of the instrument channel of the subject device was thoroughly inspected from the opening at the distal end to the suction connector of the endoscope connector and it was found that there were scratches at the bending section.There were no buckling, scratches, dirt or foreign material adhesion observed inside the instrument channel other than the bending section.There were dents and scratches at the distal end portion but significant dirt, foreign material adhesion or scratches were not observed around the instrument channel port, the suction cylinder, and the air/water cylinder.The maximum angulation cannot be achieved.The angulation control knob was loose.There were scratches on the bending rubber.The glue to fix the bending rubber to the insertion tube was partially missing.There were scratches and wrinkle on the insertion tube.The glue around the objective lens was peeling.The distal end part was smashed.There were scratches on the cover of the remote switch 3.The coating of the air/water cylinder and the suction cylinder were peeling.The exact cause of the reported event could not be conclusively determined.

• Brand Name: EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8273302
• MDR Text Key: 135192479
• Report Number: 8010047-2019-00943
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• PMA/PMN Number: K011151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1