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

Model Number EG29-I10

Device Problem Device Reprocessing Problem (1091)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Hoya corporation pentax (b)(4) office, specification developer, registration no.9610877 (b)(4).(b)(4) (importer) is submitting the report on behalf of hoya corporation pentax (b)(4) office (exemption number e2015036).

Event Description

On (b)(6) 2017, pentax medical (b)(4) was made aware of a report upon receipt of pentax model eg29-i10/serial (b)(4).The report stated non-compliant sampling.Additional information received from the customer indicated the facility reprocessed the device with anioxyde 1000 disinfectant and sampled the device after each reprocessing.In addition, the customer confirmed the device had not been put into service since it was received from pentax medical.Pentax medical received results of the sampling as follows: sampling performed on (b)(6) 2017 indicated 5,6 cfu/100ml of viable bacteria.Sampling performed on (b)(6) 2017 indicated 0,6 cfu/100ml of viable bacteria and 0,6 cfu/100ml of pseudomonas aeruginosa.Sampling performed on (b)(6) 2017 indicated 2,9 cfu/100ml of viable bacteria and 2,1 cfu/100ml of acinetobacter sp.The device was shipped from pentax (b)(4) to pentax (b)(64 for evaluation.

• Brand Name: PENTAX
• Type of Device: VIDEO GASTROSCOPE
• 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: matthew vernak ; 3 paragon drive; montvale, NJ 07645 ; 2015712300
• MDR Report Key: 6966156
• MDR Text Key: 90747511
• Report Number: 9610877-2017-00636
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/20/2017,07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2017
• Distributor Facility Aware Date: 07/21/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2017
• Date Manufacturer Received: 07/21/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1