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

Model Number HS-D2622

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Pentax medical became aware of a report on (b)(4) 2018, stating the "internal wire of hemostat wide cup snapped while attempting to close forceps.Scope had to be removed from patient to recover device" of a pentax medical bi-polar hot hemostasis forceps model number hs-d2622, serial number: (b)(4).There was no adverse event to the user or patient was reported.The product is not available for return evaluation.

• Brand Name: PENTAX
• Type of Device: HEMOSTASIS 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: william goeller (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 8219997
• MDR Text Key: 132779026
• Report Number: 9610877-2019-00167
• Device Sequence Number: 1
• Product Code: EMD
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2019,12/06/2018

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: HS-D2622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/04/2019
• Distributor Facility Aware Date: 12/06/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/04/2019
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1