MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; FIBEROPTICINTUBATIONSCOPE 1.8C 4.1TP ROP

Model Number FI-13RBS

Device Problem Optical Problem (3001)

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

Event Date 10/08/2021

Event Type  malfunction  

Manufacturer Narrative

If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Connected to the light source,the lamp did not lit.Considered poor contact and replaced the scope.No harm was caused to patient.The time of event is before use.

Manufacturer Narrative

We couldn't investigate because the device was not returned.If additional information becomes available, a supplemental report will be filed with the new information.

• Brand Name: PENTAX
• Type of Device: FIBEROPTICINTUBATIONSCOPE 1.8C 4.1TP ROP
• 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 ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 12791617
• MDR Text Key: 282103240
• Report Number: 9610877-2021-01561
• Device Sequence Number: 1
• Product Code: CAL
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/16/2021

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
• Device Operator: Health Professional
• Device Model Number: FI-13RBS
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2021
• Initial Date FDA Received: 11/10/2021
• Supplement Dates Manufacturer Received: 11/08/2021
• Supplement Dates FDA Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1