MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; RUBBER INLET SEAL SINGLE PIECE , STD

Model Number OF-B190

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Pentax medical became aware of an event that occurred on (b)(6) 2020 in the operating room during use in (b)(6).The reported complaint involved a pentax medical accessories, model of-b190, lot number unknown.The user facility reported an event stating " during the endoscpic procedure, the rubber inlet seal (of-b190) was damaged and the fluids were leak into the outside." no serious injury or death of a patient or user was reported.The damaged status of the inlet seal was confirmed.Replaced the damaged inlet seal with a new one.

• Brand Name: PENTAX
• Type of Device: RUBBER INLET SEAL SINGLE PIECE , STD
• 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: william goeller (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 10996284
• MDR Text Key: 246626292
• Report Number: 9610877-2020-00256
• Device Sequence Number: 1
• Product Code: EOB
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K172156
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/11/2020

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 Operator: Health Professional
• Device Model Number: OF-B190
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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