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

Model Number H-S2518

Device Problems Failure to Power Up (1476); Material Deformation (2976); Unintended Movement (3026)

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

Event Date 07/08/2022

Event Type  malfunction  

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.

Event Description

Use h-s2518 ((b)(4)) product.This product was opened to stop bleeding during gastric esd, inserted into a scope, and then the electrode cord was connected to a high-frequency device (vio300d).The forceps of this product were placed open at the bleeding point and energized.Initially, it was able to be energized, but since it was no longer energized in the middle, the use of this product was discontinued.There was no report of patient harm.The time of event is during use.

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 following was confirmed about the device the device was considered to have been cleaned at a medical institution before being returned to us, so a small amount of blood, etc.Was adhered to the wire at the tip.When the control unit was slid, one cup opened and closed normally, but the other cup did not open and close because the link to the wire was disconnected.The device was connected to an inspection electrosurgical instrument (vio300d) to conduct an output test, and the cup was not energized because the link between the cup and the wire was disconnected.From the above, it was considered that when the product in question was temporarily removed from the endoscope during use and coagulated tissue or blood adhering to the cup was removed with gauze or the like, the gauze or the like caught on the wire, causing the wire to deform.When checking the opening and closing of the cup, the wire was gradually pulled toward the actuator and the link with the cup was disconnected, possibly resulting in an energization failure.

• 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: 15127489
• MDR Text Key: 304545280
• Report Number: 9610877-2022-00529
• 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: 02/25/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1