MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX VIDEO CYSTOSCOPE

Model Number ECY-1575K

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2019

Event Type  Malfunction  

Manufacturer Narrative

(b)(4). Pma/510k: pentax medical model dp-d2518 is not distributed in the usa, therefore the pma/510(k) number is not applicable. (b)(4).

Event Description

Pentax medical was made aware of a complaint on (b)(6) 2019 that occurred in (b)(6). The reported complaint of "bending rubber section of the scope was damaged when removed from patient" involving the pentax medical video cystoscope during a procedure. No serious injury or death of a patient or user, or delay in the procedure which would require medical intervention was reported. Pentax medical (b)(4) sales rep provided an image of the failure and model: ecy-1575k, serial number (b)(4) on 29mar2019. Currently awaiting requested additional information.

• Brand Name: PENTAX
• Type of Device: VIDEO CYSTOSCOPE
• 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 goeller (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 8482843
• MDR Text Key: 142651035
• Report Number: 9610877-2019-00272
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): N
• Reporter Country Code: CA
• PMA/PMN Number: REFER TO H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: FOREIGN,HEALTH PROFESSIONAL
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial
• Report Date: 04/03/2019,03/07/2019

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 04/04/2019
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: ECY-1575K
• Was Device Available For Evaluation?: No Answer Provided
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/03/2019
• Distributor Facility Aware Date: 03/07/2019
• Event Location: Hospital
• Date Report TO Manufacturer: 04/03/2019
• Date Manufacturer Received: 03/07/2019
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: No Answer Provided
• Is this a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage