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

Model Number GIF-H190

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2019

Event Type  malfunction  

Manufacturer Narrative

The scope was returned to the service center but the investigation is in progress. A review of the service history indicated the scope was purchased on september 11, 2018 with no repair records. In addition, an olympus endoscopy support specialist (ess) was requested to be dispatched to the user facility to observe the facility¿s reprocessing practice and to provide a reprocessing training. To date, the ess visit has not been finalized. If additional information becomes available, this report will be supplemented accordingly.

Event Description

The service center was informed that on (b)(6), 2019 the scope's culture tested positive for pseudomonas aeruginosa, carbapenemase and an unspecified multi-drug resistant (mdr) bacteria. The scope was recultured on (b)(6) 2019 and subsequently tested positive for stenotrophomonas maltophilia, pseudomonas aeruginosa and klebsiella pneumoniae. The scope was cleaned utilizing a large brush and was cultured again on (b)(6) 2019 and the scope culture tested positive for pseudomonas aeruginosa, carbapenemase, an unspecified mdr and stenotrophomonas maltophilia; sterility check was negative. There was no death or serious injury reported.

Manufacturer Narrative

The scope was sent to an independent laboratory for culture testing. The scope¿s auxiliary water channel tested positive for staphylococcus epidermidis, the scope's air/water tested positive for bacillus circulans and the instrument/suction channel tested positive for pseudomonas aeruginosa. The scope was then ethylene oxide (eto) sterilized and returned to the service center for a physical device evaluation. The evaluation is in progress. If additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

The endoscopy support specialist (ess) visited the user facility and performed observation of the staff's reprocessing. At facility. The facility has created their own pre-cleaning checklist for bedside cleaning so the staff declined the reprocessing in-service training. After observation, i recommended to the customer that they should make sure the non-olympus (conmed) cleaning brushes they use are validated for the s scopes because the channel opening brush between the oem brushes and conmed brushes are different in size and the conmed channel opening brush looks smaller. Additionally, the facility utilizes scope buddy for manual flushing instead of manual flushing of the scopes.

Manufacturer Narrative

The referenced scope was returned to the service center for evaluation. A visual inspection was performed on both the instrument and suction channels. The instrument channel had major tear marks near the distal end side. Additionally, the instrument channel has stains along the wall that are located near the control body side. The suction channel, had a large scrape mark near the opening at the scope connector side, but there was no signs of foreign material, or stains present within. The scope passed the leak test. The air/water and auxiliary channel were inspected. The air/water channel was inspected after removal of the nozzle; the air/water channel had no signs of foreign material. The auxiliary channel was disconnected from inside the connector, there was no foreign material present within. Further finding's include; discolored, cracked and uneven bending section cover glue at the insertion tube side. The service group found deep indentations and scratches on the distal end cover and the distal light guide lens was cracked. Based on the physical condition the likely cause of the dents at the distal end, cracked light guide lens and tear marks inside the instrument and suction channels can be attributed to excessive force/stress from handling and an open or broken instrument being inserted into the instrument/suction channel. The scope was repaired and returned to the user facility. A review of the service history indicated the scope was purchased on september 18, 2018 with no previous repair records. Based on the endoscopy support specialist's (ess) observation, failing to immediately clean the scope after procedure cannot be ruled out as a contributory factor. Investigation the cause of the reported positive culture cannot be determined.

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 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: 9382091
• MDR Text Key: 208117011
• Report Number: 8010047-2019-04101
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305290
• UDI-Public: 04953170305290
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/27/2019
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: GIF-H190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 01/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse