MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; SUCTION VALVE (RUBBER)

Model Number OF-B53

Device Problem Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This mdr was initiated as part of a capa-driven remediation effort related to filing of mdrs for complaints/events outside of the us (ous).As part of this remediation, pentax medical performed a retrospective mdr assessment of all ous events/complaints received since (b)(6) 2015.The retrospective assessment of this event prompted pentax medical to file this report.(b)(4).

Event Description

Pentax medical was made aware of a report for an event which occurred outside the usa stating during endsocopy act, of-b53 splashing out liquid infection on medical and non-medical staff.

Manufacturer Narrative

9610877-2016-00150 is being submitted for the first valve.9610877-2016-00151 is being submitted for the second valve.(b)(4).Exemption number e2015036.

Event Description

The facility reported the event to (b)(6).Per pentax europe, the facility stated the suction valve got disconnected during the procedure, and liquid was splashing out and onto the staff.This occurred with 2 different valves and 2 different scopes.Pentax europe stated the bronchoscopes did not contribute to the events.In addition, the ifu requests any user to wear protective garment.The suction valve mentioned in this report was disposed by the facility, therefore no investigation could be performed on the valve.Lot numbers were provided for the valves involved in the incident, however a device history review could not be performed confirming if the suction valves were manufactured under normal conditions, passed all required inspections, and were released accordingly since the lot numbers provided are not recognized as valid lot numbers and do not exist in our manufacturing database.According to pentax europe, (b)(6) closed the file without any requests.No further information has been received for this event, therefore pentax considers this medwatch report closed.

• Brand Name: PENTAX
• Type of Device: SUCTION VALVE (RUBBER)
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi; tokyo, 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi; tokyo, 196-0 012; JA 196-0012
• Manufacturer Contact: matthew vernak ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 5805246
• MDR Text Key: 50133477
• Report Number: 9610877-2016-00150
• Device Sequence Number: 1
• Product Code: FAM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K951576
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/09/2018,04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OF-B53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/09/2018
• Distributor Facility Aware Date: 04/22/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2018
• Date Manufacturer Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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