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

Model Number OTV-S7H-NA-10Q

Device Problem Crack (1135)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned, and the investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, the autoclavable camera head had a crack in the connection section and in center of cable.There were no reports of patient harm.

Event Description

The issue was first noticed during cleaning after surgery.The intended therapeutic procedure (endoscopic sinus surgery) was completed with the same device.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on the information supplied by the manufacturer and the customer.The device was returned to olympus for evaluation and the customer's allegation crack in camera head connection section and in center of cable was confirmed.Additionally, other evaluation findings include the following: water immersion in the imaging of the main unit, and image noise.Device history record (dhr) review: a dhr was reviewed and no issues that could have caused or contributed to the reported issue were found.Instructions for use (ifu): in the instruction manual "precautions for cleaning, disinfection, and sterilization" and "storage," the following statement is found in the "warning" section.Do not clean, disinfect, or sterilize this product together with tweezers, forceps, or scalpels.There is a risk of puncturing the camera cable and destroying the electrical circuitry inside the product due to water leakage.The following statement is included in the "warning" section of the instruction manual "for safe use_endoscope image disappearance and freezing.Do not bump or drop the product.Water leakage may cause damage to the product's internal electrical circuits.The following is described in "warning" in the instruction manual "how to use": - do not use the product in a place where the endoscopic images or functions are abnormal.If the endoscope image or function becomes abnormal and returns to normal spontaneously, there is a possibility that the equipment has already malfunctioned.If you continue to use the device as it is, the abnormality may occur again and the device may not return to normal.In this case, discontinue use immediately and slowly pull the endoscope out of the patient.Continued use of such an instrument may injure the patient or cause bleeding or perforation.The most probable cause of the complaint is cause traced to component failure.Olympus will continue to monitor the field performance of 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 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18490055
• MDR Text Key: 333019889
• Report Number: 3002808148-2024-30116
• Device Sequence Number: 1
• Product Code: GCJ
• 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,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

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 Model Number: OTV-S7H-NA-10Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2024
• 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