MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA III XENON LIGHT SOURCE

Model Number CLV-190

Device Problem Poor Quality Image (1408)

Patient Problem Rupture (2208)

Event Date 01/17/2024

Event Type  Injury  

Event Description

It was reported that during therapeutic laparoscopic cholecystectomy under general anesthesia (intubation) due to gall stones with cholecystitis the brightness of light source was insufficient and it was difficult to separate the gallbladder bed.As a result, the gall bladder ruptured, and bile leaked in the abdominal cavity.The bile was completely aspirated.Details of the patient's current condition, procedural details and outcome of the procedure were requested but not available at the time of the report.

Manufacturer Narrative

The device was returned and the evaluation found the scope socket was deformed, so there was resistance of the scope socket, resulting in accidental unusable light brightness due to output connector failure.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EVIS EXERA III XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18726514
• MDR Text Key: 335718661
• Report Number: 3002808148-2024-01480
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLV-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2014
• 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: EVIS EXERA III VIDEO SYSTEM CENTER CV-190, SN-UNK
• Patient Outcome(s): Required Intervention