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

Model Number KH-2415S

Device Problems Break (1069); Device Issue (2379)

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

Event Date 03/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This mdr was initiated as part of a capa-driven remediation effort related to filing of mdrs for complaints/events outside of the us (ous).As part of this remediation, pentax medical performed a retrospective mdr assessment of all ous events/complaints received since october 2015.The retrospective assessment of this event prompted pentax medical to file this report.(b)(4).

Event Description

Pentax medical was made aware of a report for an event which occurred outside the usa stating "broken biopsy forceps handle.Hanger for thumb ring broken".

Event Description

The forceps were returned to pentax europe for evaluation.The evaluation confirmed the cups were deformed as a result of misuse and the broken rings were a result of wear and tear.Pentax europe executed 3 good faith efforts to obtain additional information surrounding the event.No further information was obtained.A replacement was provided to the customer.On 13-dec-2017, a device history review was performed confirming the forceps 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.Pentax medical has not received further information for this event and therefore considers this medwatch report closed.

Manufacturer Narrative

(b)(4) (exemption number e2015036).

• Brand Name: PENTAX
• Type of Device: FORCEPS, SPIKE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi; tokyo, 196-0 012; JA 196-0012
• MDR Report Key: 5805998
• MDR Text Key: 50557249
• Report Number: 9610877-2016-00146
• Device Sequence Number: 1
• Product Code: GCL
• Combination Product (y/n): N
• PMA/PMN Number: K951198
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 02/23/2018,03/04/2016

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: KH-2415S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/23/2018
• Distributor Facility Aware Date: 03/04/2016
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2018
• Initial Date Manufacturer Received: 03/04/2016
• Initial Date FDA Received: 07/19/2016
• Supplement Dates Manufacturer Received: 03/04/2016
• Supplement Dates FDA Received: 02/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1