MAUDE Adverse Event Report: HOYA CORPORATION PENTAX PENTAX; VIDEO COLONOSCOPE - I10 SLIM

Model Number EC34-I10L

Device Problem Failure to Disconnect (2541)

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

Event Type  malfunction  

Manufacturer Narrative

This model is classified as import for export and not distributed in the united states, therefore 510k is not applicable.We do have similar model ec34-i10l-us available in the united states with a 510k number k131855.(b)(4).If additional information becomes available, a supplemental report will be filed with the new information.Mdr 9610877-2021-01396 is being submitted for the pentax medical video colonoscope, model ec34-i10l, serial number (b)(4), index patient case.Mdr 9610877-2021-01497 is being submitted for the pentax medical video colonoscope, model ec34-i10l, serial number (b)(4), patient 01 case.Mdr 9610877-2021-01501 is being submitted for the pentax medical video colonoscope, model ec34-i10l, serial number (b)(4), patient 02 case.

Event Description

Pentax medical was made aware of an event that occurred in the united states.The customer reported that boston scientific resolution 360 hemoclips fell out of the endoscope during the high level disinfecting process involving pentax medical video colonoscope, model ec34-i10l, serial number (b)(4).The facility is not aware of any patient injury.They are also not sure where the clips were "hiding".Additional information was provided from the user facility on 25-oct-2021.The customer stated "after 3 clips came out of the insertion tube on 2 different washes, this scope was used on 2 different patients.We then sent it out for repair right when we had the second incident happen.There were 2 patients involved after the clips have been used on another patient." the complaint specialist required further clarification and additional information from the user was provided.The endoscope was used on the index patient and boston scientific resolution 360 hemoclips were used on the patient during the case and was reprocessed after the procedure.The hemoclips unknowingly remained in the endoscope.The endoscope was then used on patient 01 and after the patient 01 procedure, hemoclips fell out during reprocessing.After reprocessing the endoscope was then used on another patient, patient 02, and during reprocessing hemoclips again came out of the endoscope.Neither patient 01 or patient 02 cases involved hemoclips.An additional response with physician's comments was received 28-oct-2021.The procedure was a screening with polyps removed.There was no delay during the procedure and the endoscope was used to complete the procedure.The facility responded yes, the accessories became stuck during the current (initially) procedure and did say it was possible risk for cross contamination or other patient risk.There were no known injuries and the patient was tested for (b)(6).Patient information was requested, but will not be provided by the user facility.Patient 01 and patient 02 have not been tested and no signs of symptoms have been reported as of 03-nov-2021.The endoscope was received by pentax medical for evaluation on 19-oct-2021.The endoscope was inspected by pentax medical service repair under service order (b)(4) and the following inspection findings were documented: operation channel- primary slice by accessory, passed dry leak test, passed wet leak test, segment screw loose at insertion tube, control body root brace loose.Additionally light carrying bundle has less than 70% transmission was noted.Although there were no hemoclips found during the service repair, the endoscope is undergoing repairs including the following components: o-rings and seals, bending rubber, angle wire assy, adjusting collar, operation channel, x-ring (1.8x19.6) gray, light guide fiber bundle (lcb), rl lock rotating disk, rl lock base unit.The endoscope is awaiting repair and approved by final qc as of 11-nov-2021.Model ec34-i10l, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service.On 08-nov-2021, a device history record(dhr) review for model ec34-i10l, serial number (b)(4) was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured in the (b)(4) facility on 10-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 10-jun-2019.Instructions for use(ifu), includes the following warning section 2-1-3, 3) "after using operational/ cleaning accessories (e.G., forceps, needles, snares, brushes etc.) with the endoscope, carefully check that all accessories are intact and that no parts have fallen off and become lodged within the endoscope's instrument/suction channel.Furthermore, ensure that any therapeutic devices (e.G., clips, stents, etc.) passed through the channel are accounted for after use.On 06-apr-2016, pentax issued a u.S.Urgent field correction which is an ifu addendum for endoscopes with instrument channels.This addendum covers any operational/ cleaning accessories and therapeutic devices which can become lodged in the endoscope's instrument channel.It reminds customers to carefully check that all accessories are intact, that no parts have fallen off and become lodged within the endoscope's instrument/ suction channel and to ensure that any therapeutic devices (e.G., clips, stents, balloons, etc.) passed through the instrument channel and are accounted for after use.

• Brand Name: PENTAX
• Type of Device: VIDEO COLONOSCOPE - I10 SLIM
• Manufacturer (Section D): HOYA CORPORATION PENTAX; 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: 12800972
• MDR Text Key: 284986611
• Report Number: 9610877-2021-01396
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04961333186822
• UDI-Public: 04961333186822
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: REFER TO H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EC34-I10L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1