MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA 4K UHD XENON LIGHT SOURCE

Model Number CLV-S400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Hemorrhage/Bleeding (1888); Pain (1994); Perforation (2001); Foreign Body In Patient (2687); Unspecified Hepatic or Biliary Problem (4493)

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

Olympus reviewed the following literature: "is 3d faster and safer than 4k laparoscopic cholecystectomy? a randomised-controlled trial."   literature summary: this randomized controlled study discussed about is 3d faster and safer than 4k laparoscopic lecystectomy.Patients undergoing laparoscopic cholecystectomy were randomised to 3d hd or 4k laparoscopy.Operative videos were recorded, and the time from gallbladder exposure to separation from the liver (minus on table cholangiogram) was calculated.There were 120 patients were randomized and out of that, 109 were analyzed.There were no reduction in operative time was detected with 3d hd compared to 4k laparoscopy.Stone spillage occurred more frequently with 3d hd, but there were no other dif differences in individual error rates.The study was concluded that a 3d hd laparoscopic system did not reduce operative time or error scores during laparoscopic cholecystectomy compared with a new 4k imaging system.    type of adverse events/number of patients: gallbladder injury with stones spilled (n=1), livery injury with bleeding (n=5), cystic artery injury (n=6), perforated gallbladder with suture closure.30-day complications/re-admission? post op pain/reattendance (n=2), intraoperative dysrhythmia (n=1), urinary retention (n=1).Gallbladder injury with bile spilled (n=16), diathermy liver injury (n=11), clip fell into abdomen (n=2).Since the literature described "visera 4k uhd system", we selected "otv-s400" and "clv-s400" as representative products.Two complaints (otv-s400 and clv-s400) are created for mdr.This is 2 of 2 reports for this article.

Manufacturer Narrative

This supplemental report is being submitted to provide the legal manufacturer's investigation.New information added to the following fields: h6, h10; correction to initial report b5 and h6.B5, h6: upon further evaluation by the legal manufacturer, the following events have been determined to be non-serious: injury to gallbladder with bile spilled -(16), liver injury by diathermy -(11), misplaced clip fallen into abdomen -(2).The device history records (dhr) for this device could not be reviewed since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer was unable to determine the probable cause of the adverse events since the device was not returned for evaluation.

• Brand Name: VISERA 4K UHD XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• 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: 14270628
• MDR Text Key: 293301296
• Report Number: 8010047-2022-07435
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170374579
• UDI-Public: 04953170374579
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K151011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CLV-S400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2022
• 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: UNKNOWN SERIAL: OTV-S400
• Patient Outcome(s): Other; Required Intervention