MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; FORCEPS

Model Number KW-2415R

Device Problem Disconnection (1171)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pentax model kw-2415r is not sold in the usa, therefore 510(k) is not applicable.(exemption number e2015036).

Event Description

Pentax medical was made aware of a report for an event which occurred in (b)(6) at (b)(6).The report stated, "the forceps was broken while first time used (broken, fell apart in the end-user`s hand during the first biopsy procedure taken)".Pentax medical requested reprocessing information from the user along with requesting return of the device to pentax medical for evaluation.Pentax medical received reprocessing information from the user, however the device was not returned for evaluation.

• Brand Name: PENTAX
• Type of Device: FORCEPS
• 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: 7022786
• MDR Text Key: 92812044
• Report Number: 9610877-2017-00638
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• PMA/PMN Number: REFER TO H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2017,10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KW-2415R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/10/2017
• Distributor Facility Aware Date: 10/18/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/10/2017
• Initial Date Manufacturer Received: 10/18/2017
• Initial Date FDA Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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