MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA SINGLE USE GUIDWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number N/A

Device Problem Peeled/Delaminated (1454)

Patient Problem Insufficient Information (4580)

Event Date 12/12/2022

Event Type  malfunction  

Event Description

The user facility reported that the guide wire has about 2 to 3 cm the metal is not covered.

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was not returned for evaluation.Review of the manufacturing record and shipping inspection record of the actual sample found no anomaly in them.A search of the past complaint file found no other similar report with the involved product code/lot number.According to the investigation results, no anomaly was found in the manufacturing record and shipping inspection record, and no similar events were reported from other facilities.Since the actual sample was not returned, the cause of occurrence could not be clarified.Please refer to the following warning indicated in the instructions for use (ifu) of this product.Before use, prepare and inspect the instrument as instructed below.Should the slightest irregularity be suspected, do not use the instrument; use a spare instead.Damage or irregularity may compromise patient or user safety, present an infection control risk, cause tissue irritation and patient injury such as punctures, hemorrhages, mucous membrane damage or thermal injury and may result in more-severe equipment damage.Terumo medical products (tmp) (importer) registration no: (b)(4) is submitting this report on behalf of ashitaka factory of (b)(4) corporation (manufacturer) registration no: (b)(4).

Manufacturer Narrative

This report is being submitted as follow-up no.1 to correct section h6.In the initial report section h6 investigation findings and investigation conclusions was inadvertently left blank.

• Brand Name: SINGLE USE GUIDWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 6402040886
• MDR Report Key: 16128643
• MDR Text Key: 308733918
• Report Number: 9681834-2022-00277
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D456910
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2023

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: N/A
• Device Catalogue Number: OL-XA35455M
• Device Lot Number: 220603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 01/10/2023
• Supplement Dates Manufacturer Received: 01/10/2023
• Supplement Dates FDA Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1