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  

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.The date of march 08, 2023, reflected on f13 is when olympus became aware of a non-reportable malfunction.The date of april 14, 2023, reflected on f6 is when olympus became aware of a serious injury caused by a device malfunction through additional information received from the customer.This importer medwatch is being submitted for the serious injury caused by the device malfunction 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
• MDR Report Key: 16924233
• MDR Text Key: 315192336
• Report Number: 2429304-2023-00098
• 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: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/08/2023,05/12/2023

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?: Yes
• Distributor Facility Aware Date: 04/14/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLV-190 / (B)(6); CV-190 / UNKNOWN SERIAL NUMBER; MAJ-1430 / UNKNOWN SERIAL OR LOT NUMBER
• Patient Outcome(s): Other