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	04/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: it was caused due to a malfunction of the us balloons.It is random failure.This report is being filed as part of the pentax backlog management plan.
Event or Problem Description
Brand new us-balloons leaky.This event occurred at the time of before use.There was no report of patient harm.

• 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: 12222559
• Report Number: 9610877-2021-10215
• Device Sequence Number: 17049206
• 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
• Report Date (Section B): 07/24/2021

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: Health Professional
• Device Model Number: OF-A67
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/3021
• Initial Report FDA Received Date: 07/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1