MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. AUTOCLAVABLE CAMERA HEAD

Model Number OTV-S7H-1NA-10E

Device Problem Image Display Error/Artifact (1304)

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

Event Type  malfunction  

Event Description

The customer contacted olympus to report lines in the images coming from their autoclavable camera head during pre-operation inspection for a laparoscopic inguinal hernia pediatric surgery.The camera head was replaced before the procedure using the same peripheral devices.No patient or user harm has been reported.During preliminary testing and inspection of the returned device, the reported issue of image lines was confirmed.This mdr is being submitted to capture the reportable malfunction found.

Manufacturer Narrative

The device has been returned to olympus for preliminary evaluation, and the reported problem has been confirmed; lines on the images from the camera head were found.In addition to confirmation of the reported problem, physical stress, scratches, and wear and tear were found on the cable/connector, head main body, head scope mount, and head free lock lever.Flex discoloration was found on the imaging head section, and the imaging head / cable were submerged.This investigation is ongoing, and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if additional information becomes available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the reported issue was faulty cable.Broken cable was described on the instruction manual.·do not coil the camera cable with a diameter of less than 20 cm.The camera cable may be damaged.·never excessively pull the camera cable, but straighten it gradually when it is coiled.The camera cable could be damaged.·never excessively bend, pull, twist, coil, squeeze, or crush the camera cable.The camera cable could be damaged.·do not use excessive force when wiping the external surfaces of the camera cable.The camera cable could be damaged.·never attempt to lift the entire assembly by the camera cable while the camera head is attached to the endoscope.The camera cable could be damaged.·never use a clamp or forceps to attach the camera cable to another object.The camera cable could be damaged.Olympus will continue to monitor field performance for this device.

• Brand Name: AUTOCLAVABLE CAMERA HEAD
• Type of Device: CAMERA HEAD
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15753158
• MDR Text Key: 307663441
• Report Number: 3002808148-2022-03926
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170141836
• UDI-Public: 04953170141836
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K955404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OTV-S7H-1NA-10E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 11/25/2022
• Supplement Dates FDA Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2004
• 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: 3MM LAPAROSCOPIC.; AMCO 3MM YELLOW PORT.; OLYMPUS OTV-S190.; STORZ 3MM SCOPE.
• Patient Sex: Male