MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE - I10 STANDARD

Model Number EG29-I10C

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 05/04/2023

Event Type  malfunction  

Manufacturer Narrative

At this time, the target endoscope is not specified.Therefore, we submit mdr for all endoscopes owned by this customer.We checked the pictures and it looks like teflon.White silicone is used to seal between fittings.When this glue dries, it looks like a low resistance white paste.Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Stretchable white filaments found in operator channels and in aer connectors.All i10c scopes were sold on 2022-07-27.This event occurred at the time of reprocessing.There was no report of patient harm.This event meets the requirements for fda reportability; however, submission of this report does not constitute an admission that medical personnel, user facility, importer, manufacturer or product caused or contributed to the event.

Manufacturer Narrative

Additional information: the pentax medical emea, responded to a good faith effort request via email on 25-may-2023.That the model name is incorrect.Therefore, we submit a supplemental report with the model name corrected.The investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.

Manufacturer Narrative

Correction information b4: date of this report g6: follow up #2 h2:if follow-up, what type? h3:device evaluated by manufacture h6: coding changed based on the investigation result evaluation summary as a result of the investigation completed on (b)(6) 2023, it was considered possible that the foreign material found was part of the (b)(4) (cleaning brush), but the user did not purchase the (b)(4).We also found no defects in the product.Based on the above, we conducted another decision tree on (b)(6) 2023, and determined that this complaint was not reportable to mdr report.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

• Brand Name: PENTAX
• Type of Device: VIDEO GASTROSCOPE - I10 STANDARD
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 19600 12; JA 1960012
• 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: 16990539
• MDR Text Key: 316709132
• Report Number: 9610877-2023-00148
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K190805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 07/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG29-I10C
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1