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

Model Number H-S2518

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2022

Event Type  malfunction  

Event Description

When (b)(4) was stopped from bleeding with the product, taken out from the endoscope, and the blood was wiped off with gauze, a catch was felt at the tip.There was no report of patient harm.The time of event is during use.

Manufacturer Narrative

This device is not distributed in us so that unique identifier is blank.This device is not distributed in the usa, therefore the pma/510(k) number is not applicable.If additional information becomes available, a supplemental report will be filed with the new information.

Manufacturer Narrative

Correction information g6: follow up #1 h2:if follow-up, what type? h3:device evaluated by manufacture.H6: coding changed based on the investigation result.Additional information h4:device manufacture date.Evaluation summary the wire connecting the cup to move it had become deformed.It is thought that the gauze got caught on the wire and deformed the wire when the product was temporarily removed from the endoscope and the clotted tissue and blood adhering to the cup were removed with gauze.

• Brand Name: PENTAX
• Type of Device: FORCEPS WINDOW REUSABLE
• 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 ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 15127491
• MDR Text Key: 304440688
• Report Number: 9610877-2022-00530
• Device Sequence Number: 1
• Product Code: KGE
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H-S2518
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1