MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE

Model Number EG29-I10

Device Problems Partial Blockage (1065); Break (1069); Failure to Disconnect (2541); Physical Resistance/Sticking (4012)

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

Event Date 08/27/2021

Event Type  malfunction  

Event Description

Pentax medical was made aware of an event which occurred in the pai region involving pentax video scope eg29-i10.In the event reported, it was stated that the device primary channel blocked.The customer stated it is not blocked but feels like it is not smooth like rough.Able to put forceps through but rough.The customer also stated that forceps, as an accessory, was used during the procedure and there were no patient/user injuries, adverse events, delay, or medical intervention reported.Has no video image.The anomaly was discovered in the procedure room during use.There was no adverse event reported with this complaint.The device was returned to pentax medical service department for further evaluation on service order (b)(4) and was inspected by the technician where the user narrative was confirmed.Inspection findings are as follows: suction tube resistance; passed dry leak test; lightguide prong cover glass set loose; passed wet leak test; insertion tube bump at end of root brace; water nozzle clogged with inorganic debris; air/ water nozzle glue worn; customer complaint confirmed.The device is currently pending repairs and will be returned to the user upon completion.Parts to be replaced: o-rings and seals; suction channel lg; air/water nozzle collar; water nozzle.A review of the service history indicates the device was not routinely serviced at pentax.No other information provided.

Manufacturer Narrative

(b)(4).If additional information becomes available, a supplemental report will be filed with the new information.

Manufacturer Narrative

Correction information g6: follow up #1.H2:if follow-up, what type?.H3:device evaluated by manufacture.H6: coding changed based on the investigation result.Additional information.D4:unique identifier (udi).H4:device manufacture date.H7:if remedial action initiated, check type.Evaluation summary this is an event in which a foreign matter such as a brush clogs the pipe.The cause is thought to be that the brush used by the user during cleaning was broken and remained in the pipe.Pentax has added a method for alerting and detecting in ifu in the event, and also implemented field action.

• Brand Name: PENTAX
• Type of Device: VIDEO GASTROSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0012 ; JA
• 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: 12477779
• MDR Text Key: 283607791
• Report Number: 9610877-2021-00531
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333223909
• UDI-Public: 04961333211692
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 12/07/2022

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: EG29-I10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2021
• Initial Date FDA Received: 09/15/2021
• Supplement Dates Manufacturer Received: 08/27/2021
• Supplement Dates FDA Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1