MAUDE Adverse Event Report: UNKNOWN UNKNOWN; VIDEOSCOPE

Model Number UNKNOWN

Device Problems Moisture Damage (1405); Poor Quality Image (1408)

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

Event Date 03/08/2023

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.

Event Description

The customer reported to olympus that the evis exera iii light source lamp had over 500 hours.A bright image, and an error code were also observed.Olympus technical assistance center (tac) assisted the customer with replacing the lamp and clearing the error code, but the image issue persisted.It was concluded that the issue was on the videoscope cable exera ii.The customer indicated they will use another cable.Additional information was later received from the customer, clarifying that an unspecified scope was also "broken" along with the "bad" videoscope cable.The customer further indicated that the pigtails for the cable and the scope were probably soaked in water causing the damage.The event occurred during an unspecified diagnostic procedure, which caused a 1-hour delay, with the patient under anesthesia.The endo cart was swapped out and a different scope and cable were used.There was no patient injury reported from the prolonged anesthesia.Although the scope used at that time is unknown, it is highly likely that an olympus scope was used for the procedure.This mdr is being submitted for the 1-hour delay caused by the broken scope and bad videoscope cable that was later reported by the customer.This event is captured under the following related patient identifiers: (b)(6) - videoscope cable.(b)(6) - unknown scope.

• Brand Name: UNKNOWN
• Type of Device: VIDEOSCOPE
• Manufacturer (Section D): UNKNOWN; unknown; unknown, unknown UNKNO WN; JA UNKNOWN
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16923994
• MDR Text Key: 315174374
• Report Number: 9610595-2023-07434
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: CLV-190 / 7668635.; CV-190 / UNKNOWN SERIAL NUMBER.; MAJ-1430 / UNKNOWN LOT NUMBER.
• Patient Outcome(s): Other