MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO UPPER G.I.SCOPE

Model Number EG29-I10

Device Problem Residue After Decontamination (2325)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/04/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information: based on the information provided, the foreign body may be tissue from a previous patient.No tissue could be recovered from the patient's body.There are no issues with the channels or any dirt inside the channel system.No harm to the patient or any other.The device passed several reprocessing's without any findings before use at customer side.We also checked the endoscope reprocessing procedures at uke and found that they were carried out using standardized procedures.According to the process, this loner scope has been reprocessed at least twice before use.Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

A loan unit had gone through the pre-wash and had been found ok (for this purpose it is sampled and sent through the rdge twice in total).During the first examination, biological material was pushed out of the working channel when a forceps was advanced.According to the uke, this material should have come from the previous patient and not from the uke.Photo of the biological material attached.It could not be removed, but the patient did not suffer any harm.This event occurred at the time of during use.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

Correction information b4: date of this report.G6: follow up #1.H2:if follow-up, what type? h3:device evaluated by manufacture.H6: coding changed based on the investigation result.Evaluation summary: there is no defect with the device and no dirt or any residues could be detected.It passed several reprocessings without any findings.Based on the investigation data, it was determined that the underlying cause/root cause of the failure was due to improper reprocessing.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 UPPER G.I.SCOPE
• 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 19600 12; JA 1960012
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 18001436
• MDR Text Key: 326450385
• Report Number: 9610877-2023-00238
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333211692
• UDI-Public: 04961333211692
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131902
• 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: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1