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

Model Number	EG-2990ZI
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ife, import for export.Event problem and evaluation codes: (b)(4).
Event or Problem Description
Pentax medical became aware of an event that occurred on (b)(6) 2020 in the operating room during use in (b)(6).The reported complaint involved a pentax medical video upper g.I.Scope, model eg-2990zi, serial number (b)(4).On (b)(6) 2020, the user facility reported by the user facility digestive endoscopy physician stating the following: on (b)(6) 2020, in the morning shift, i underwent an upper gastrointestinal endoscopy exam on the patient.There was no complication during the first moments of the exam, the same proceeding according to usual maneuvers: after the evaluation of the first duodenal portion, progress was made towards the evaluation of the second portion of the duodenum.Upon removal of the device, however, the presence of metallic material in the duodenal bulb that was not present at the initial introduction of the endoscope was observed.After analysis of the material (small cylindrical rod with a hole in the tip), it was decided to remove it with biopsy forceps.The need for such a maneuver added time to the examination, but did not cause further harm to the patient.Afterwards, it was observed that the water jet for cleaning the lenses of the endoscopy device had a linear path, and was no longer directed to the lenses." on 15-apr-2020, additional information was reported from pentax (b)(6) that the video gastroscope was used to complete the procedure, there was no injury, patient will not be recalled for further screening.Current status of the patient was reported as inpatient examination at the hospital.On (b)(6) 2020, a device history record (dhr) review was performed under ivai-20-040012, the dhr review confirmed the endoscope was manufactured on 21-jun-2019 under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed for (b)(6) 2019.This is the first time pentax medical video gastroscope, model eg-2990zi, serial number (b)(4) has been returned for service at a pentax medical facility since the device was put into service on (b)(6) 2019.Device was returned for evaluation to pentax medical at and the video gastroscope was inspected on (b)(6) 2020, as per pentax (b)(6) ta(tentative agreement).The equipment was fully inspected and tested as directed by the manufacturer and the air/water nozzle was found to be missing.According to the evaluation it is clear that the nozzle lose occurred by missing glue, because there is no residual of the glue in the bore.It is common when the nozzle comes out or is removed for cleaning, residual of the glue will stay in the bore, and this was not detected, so we concluded that there was no glue.The final investigation is pending.
Additional Manufacturer Narrative
H6 continued: international medical device regulators forum (imdrf) adverse event reporting health effect impact code: 2199 no health consequences or impact.Component code: 3092 nozzle.Investigation findings: 140 wear problem.Investigation conclusions: 4315 cause not established.The manufacturer provided an investigation summary on (b)(6) 2020 for the failure of pentax medical video gastroscope, model eg-2990zi, serial number (b)(6) summarized as follows: content of failure: detachment of air/water nozzle.Review of dhr: manufacturing records of the scope in question were reviewed.It was confirmed that the bonding process of the nozzle detached was duly implemented according to the work instruction.Also, in the final inspection, no abnormality was detected in all items and nozzle was attached at the time when the product was delivered.Risk evaluation: as the nozzle dropped into human body was already collected, it is determined not to harm the patient.Even if the nozzle is dropped into human body, the nozzle is proven to be biocompatible and naturally passed out of the body.Therefore, it is unlikely to result in significant harm and risk is considered to be low.Result of cause investigation for the failure: many scratches and dents were observed at the distal part.Causes could not be identified.However, these scratches are likely to have been made by external loading during preparation, use or re-processing.It is concluded that deterioration of adhesive caused by chemical agent and aforementioned external loading might have caused nozzle detached from the adhered surface and dropped into human body.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

• Brand Name: PENTAX
• Common Device Name: VIDEO GASTROSCOPE VERSION-C
• 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 (temporary) ; 3 paragon drive; montvale, nj ; 43158802318
• MDR Report Key: 10063014
• Report Number: 9610877-2020-00074
• Device Sequence Number: 3514151
• Product Code: FDS
• UDI-Device Identifier: 04961333240166
• UDI-Public: 04961333240166
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: REFER TO H10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EG-2990ZI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 05/15/2020
• Supplement Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female