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

Model Number EG-2990I

Device Problem Device Issue (2379)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This mdr was initiated as part of a retrospective assessment of complaints/events in the us.As part of this assessment, pentax medical evaluated all us events/complaints received for currently marketed bronchoscopes, colonoscopes, and gastroscopes.The results of this retrospective assessment prompted pentax medical to file this report.

Event Description

Pentax medical was made aware of a report stating while using eg-2990i sn: (b)(4) during the procedure, the physician (dr.(b)(6)) attempted to introduce a 2.8mm forceps through the scope, however the accessory could not pass.Dr.(b)(6) introduced a smaller device into the scope and able to pass the accessory.During insertion, he noticed a small o-ring type object was expelled from the scope during the procedure.Dr.(b)(6) was unable to retrieve the object and was not able to photograph the object.The device involved in the event was forwarded to pentax for evaluation with a customer observation stating suction channel blocked.The incoming inspection found the resistance in the operation channel.Repairs were performed on the endoscope and it was successfully shipped back to the customer.A device history review was performed on eg-2990i sn:(b)(4) confirming the scope was manufactured 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.As stated in the complaint file (closed 12/jun/2013), pentax medical is not sure where the small o-ring like object came from and an absolute cause cannot be determined.It's possible the object could have been introduced during the procedure from chipped rubber inlet seal for biopsy port or could have been introduced during the cleaning process.The complaint notification stated the customer used forceps that was 2.8mm in diameter.The customer needed to use a forceps that was a maximum of 2.6mm in the working channel of the endoscope.As per ifu the maximum outer diameter of an endoscopic accessory instrument must be at least 0.2mm less than the specified instrument channel diameter of pentax endoscopes.In this case the specification channel diameter of this model is 2.8mm.No further information has been received for this event, therefore pentax medical considers this medwatch report closed.

• 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, ; JA
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi; tokyo 196-0012, ja, ; JA
• Manufacturer Contact: krishna govindarajan ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 5681647
• MDR Text Key: 45981583
• Report Number: 9610877-2016-00044
• Device Sequence Number: 1
• Product Code: FDS
• 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
• Type of Report: Initial
• Report Date: 05/26/2016,05/17/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: EG-2990I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2012
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/26/2016
• Distributor Facility Aware Date: 05/17/2012
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/26/2016
• Date Manufacturer Received: 05/17/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2011
• 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
• Patient Outcome(s): Other