MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA LLL COLONOVIDEOSCOPE

Model Number PCF-H190L

Device Problems Contamination (1120); Material Protrusion/Extrusion (2979); Failure to Clean Adequately (4048)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/09/2022

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated, and the reported issue was confirmed.The angulation had play.Detergent solution or disinfectant solution remained on the insertion section or distal end (including each channel and nozzle).The light guide lens was cracked and had scratches and a chip.The charge-coupled device lens was chipped, scratched, and had discoloration.The plastic distal end cover was cracked had scratches, and a chip.The bending section cover glue had chip and a gap.The bending tube had shortened.The connecting tube had a pouch and a scratch.The key top one (1) was incised, had cuts.The universal cord coating peeled off.The light guide cover glass was scratched.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus, during receipt inspection, the evis exera iii colonovideoscope had an angulation malfunction.No patient harm reported.During the evaluation of the device, it was noted there was residue/foreign material on the distal end side of the connecting tube after insufficient or incorrect reprocessing.Additionally, the connecting tube had protruded.This report is to capture the reportable malfunctions of the residue/foreign material on the distal end side of the connecting tube after insufficient or incorrect reprocessing and the connecting tube had protruded noted at estimation.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the reporter.

Event Description

Additional information was received from the reporter.The issue occurred after the procedure.There was no known patient or user infections.

Manufacturer Narrative

This supplemental report is being submitted to provide a correction to (device evaluation).The device was evaluated, and the reported issue was confirmed.The angulation had play.Detergent solution or disinfectant solution remained on the insertion section or distal end (including each channel and nozzle).The light guide lens was cracked and had scratches and a chip.The charge-coupled device lens was chipped, scratched, and had discoloration.The plastic distal end cover was cracked had scratches, and a chip.The bending section cover glue had chip and a gap.The bending tube had shortened.The connecting tube had a pouch and a scratch.The key top one (1) was incised, had cuts.The universal cord coating peeled off.The light guide cover glass was scratched.The connecting tube had protruded but the blade did not protrude.

Event Description

The customer reported to olympus, during receipt inspection, the evis exera iii colonovideoscope had an angulation malfunction.No patient harm reported.During the evaluation of the device, it was noted there was residue/foreign material on the distal end side of the connecting tube after insufficient or incorrect reprocessing.This report is to capture the reportable malfunction of the residue/foreign material on the distal end side of the connecting tube after insufficient or incorrect reprocessing noted at estimation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.Based on the results of the investigation, the specific root cause of the event could not be determined at this time.The following information is stated in the instructions for use (ifu): "do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA LLL COLONOVIDEOSCOPE
• Type of Device: COLONOVIDEOSCOPE
• 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: 14592896
• MDR Text Key: 301080991
• Report Number: 8010047-2022-09356
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170305191
• UDI-Public: 04953170305191
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCF-H190L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2016
• 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