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

Model Number OF-A67

Device Problems Material Puncture/Hole (1504); Gas/Air Leak (2946); Material Split, Cut or Torn (4008)

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

Event Date 05/31/2021

Event Type  malfunction  

Manufacturer Narrative

Lot# is unavailable.We will continue to investigate this situation and if necessary, file a supplemental report.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 264089296
• Report Number: 9610877-2021-10075
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04961333113545
• UDI-Public: 04961333113545
• Combination Product (y/n): N
• PMA/PMN Number: K130247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: OF-A67
• Device Lot Number: 0021040
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1