MAUDE Adverse Event Report: HOYA CORPORATION PENTAX; BIOPSY FORCEPS WITH WINDOWS AND SPIKE

Model Number KH-2422S

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

Pentax medical received a report from a territory manager on (b)(6) 2015 stating "during procedure, when trying to grab a biopsy in the patient, the handle snapped from the biopsy forceps.Another biopsy forceps was used to complete the biopsy".This event occurred with 2 separate biopsy forceps.The second event is captured under report # 2518897-2015-00008.Good faith effort attempts were made to the territory manager on (b)(4) 2015.The territory manager indicated the product is available for return, and also stated video gastroscope model eg-2990k was being used at the time the event occurred.A third good faith effort attempt regarding product return was sent to the territory manager on (b)(4) 2015.The product is currently pending return to pentax medical for evaluation.A corrective action request will also be submitted to the manufacturer to investigate the product malfunction.

• Brand Name: PENTAX
• Type of Device: BIOPSY FORCEPS WITH WINDOWS AND SPIKE
• Manufacturer (Section D): HOYA CORPORATION; tokyo ; JA
• Manufacturer (Section G): HOYA CORP.; 2-7-5 naka-psjao,; shinjuku-ku; tokyo 161- 8525; JA 161-8525
• Manufacturer Contact: anastasia vlamis ; 3 paragon drive; montvale, NJ 07645 ; 2015712300
• MDR Report Key: 4787986
• MDR Text Key: 5857192
• Report Number: 2518897-2015-00008
• Device Sequence Number: 1
• Product Code: GCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951198
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2015,04/27/2015

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-2422S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/19/2015
• Distributor Facility Aware Date: 04/27/2015
• Device Age: 6 MO
• Event Location: Other
• Date Report to Manufacturer: 05/19/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1