MAUDE Adverse Event Report: PENTAX CORP. 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 Date 01/01/2015

Event Type  malfunction  

Event Description

Pentax medical received biopsy forceps with windows and spike model #kh-2422s/ serial # (b)(4) and a visual inspection was performed on 06/03/2015.The visual inspection confirmed breakage by the handle area.No other visual defects were noted.Good faith effort attempts were made to the initial reporter on 06/03/2015 and 06/11/2015 to confirm details of the event for the investigation and in order to be able to assess the event for reportability.A phone conversation was held with the initial reporter on (b)(4) 2015 who confirmed that the breakage occurred during procedure and no injuries to the pt or user occurred.Due to these additional details, the event was determined to be a reportable event on (b)(4) 2015.No other details surrounding the event were received from the initial reporter.Based on the info received from the initial reporter and the visual inspection performed by pentax medical, a root cause of the event cannot be determined at this time.The only possibilities are to suggest the user applied excessive force which resulted in the breakage or the breakage was a result of a mfg non-conformity.Since the root cause for this complaint is unk, a corrective action request was initiated for the mfr, along with sending the sample involved in this event, to further evaluate the product and implement any corrective actions, if necessary.Pentax medical has not received any other info regarding this event or the medical device involved, and therefore considers this medwatch report closed.

• Brand Name: PENTAX
• Type of Device: BIOPSY FORCEPS WITH WINDOWS AND SPIKE
• Manufacturer (Section D): PENTAX CORP.; tokyo ; JA
• Manufacturer (Section G): HOYA CORP., PENTAX LIFE CARE TOKYO OFFICE; 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: 4886427
• MDR Text Key: 6263218
• Report Number: 2518897-2015-00016
• 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: 06/30/2015,06/12/2015

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
• Date Returned to Manufacturer: 06/02/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2015
• Distributor Facility Aware Date: 06/12/2015
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 06/30/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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