MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; BALLOON/O-RING KIT FOR ULTRASOUND 20PCS

Model Number	OF-A67
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot# is unavailable.We will continue to investigate this situation and if necessary, file a supplemental report.
Event or Problem Description
This event occurred at the time of before use.There was no report of patient harm.There are small holes in the rubber.The balloons are leaky.
Additional Manufacturer Narrative
Evaluation summary: we have contacted a service center in emea on july 27, 2021 and august 10, 2021 if they could provide us additional information related to the complaint.They said that they did not have further information related to the patient and have been checking the responsible person in the service department to obtain any further information ; however, we have not heard any feedback from them as of august 12, 2021.We will continue to communicate it with the engineer and create a supplemental report if we have any.This report is being filed as part of the pentax backlog management plan.

• Brand Name: PENTAX
• Common Device Name: BALLOON/O-RING KIT FOR ULTRASOUND 20PCS
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12098178
• Report Number: 9610877-2021-10075
• Device Sequence Number: 11170576
• Product Code: ODG
• UDI-Device Identifier: 04961333113545
• UDI-Public: 04961333113545
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K130247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

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
• Operator of Device: No Information
• Device Model Number: OF-A67
• Device Lot Number: 0021040
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2021
• Supplement Date Received by Manufacturer: 05/31/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1