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

Model Number EG29-I10

Device Problems Partial Blockage (1065); Device Contamination with Chemical or Other Material (2944)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Pentax medical was made aware of a complaint on (b)(6) 2020 regarding "for evaluation - potential glue in working channels" involving pentax medical video gastroscope, model eg29-i10, serial number (b)(4).No serious injury or death of a patient or user, or delay in the procedure which would require medical intervention was reported.Pentax sales representative responded via email on 30-oct-2020, and stated that the glue was used on 2 separate cases during procedures.After the procedures were completed they cleaned and reprocessed the endoscopes.The user facility saw residue from the glue on the endoscope and distal tip.The endoscope is being sent in to pentax medical for service evaluation as they are not sure if the glue may have got in the internal channels of our endoscopes.The glue used is for gastric varices.The glue used is believed to be cyanoacrylate or fibrin.The customer owned gastroscope was received by pentax medical for evaluation on 11-nov-2020.The endoscope was inspected by pentax medical service under service order 3129895 and the technician was unable to duplicate the users complaint and documented the following inspection findings on 13-nov-2020: bending rubber, severe discoloration, passed dry leak test, distal body abrasion, passed wet leak test, air/ water socket o-ring chipped, scope case lock damaged.The device underwent repairs including the following components: o-rings and seals, bending rubber.Model eg29-i10, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service on 29-sep-2018.The gastroscope is pending repair or final qc approval as of 19-nov-2020.

Manufacturer Narrative

Evaluation summary: the cause could not be identified, the adhesive used was for gastric varices, and it was thought to be cyanoacrylate or fibrin, and it was determined that the problem was not caused by our product.After investigation, we were unable to reproduce a similar event.Correction information: g6: follow up #1.H2: type of follow up.H6: coding changed based on the investigation result.Additional information: h4: device manufacture date.

• Brand Name: PENTAX
• Type of Device: VIDEO GASTROSCOPE
• 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: 10875077
• MDR Text Key: 262633266
• Report Number: 9610877-2020-00227
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333211692
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2022

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: 11/11/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• Supplement Dates FDA Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2018
• 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