MAUDE Adverse Event Report: CORIN MEDICAL TRINITY; FLEXIBLE DEPTH GAUGE

Model Number 921.109

Device Problems Mechanical Problem (1384); Product Quality Problem (1506); Inadequacy of Device Shape and/or Size (1583); Mechanical Jam (2983)

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

Event Date 07/06/2021

Event Type  malfunction  

Manufacturer Narrative

Per -(b)(4) initial report.The reported device is being returned and will be reviewed at corin.Details of this review will be provided in a supplemental report upon completion of the investigation.The appropriate device details were provided and the relevant device manufacturing record has been identified and reviewed.All parts associated with this record conformed to material and dimensional specification at the time of manufacture.Please note: this report is filed with the fda due to an event experienced with a device that is similar to those placed on the market in the usa.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to the event.

Event Description

The measured value and length of the tip of the trinity flexible depth gauge were reported to be clearly different.

Event Description

The measured value and length of the tip of the trinity flexible depth gauge were reported to be clearly different.

Manufacturer Narrative

The appropriate device details were provided and the relevant device manufacturing record has been identified and reviewed.All parts associated with this record conformed to material and dimensional specification at the time of manufacture.The device was returned and the failure was confirmed.Upon investigation it was found the depth guage was not fully functional due to a manufacturing defect from an obseleted supplier.The fault was overlooked by goods inwards, as no specific insructuion was noted on the gi sheet to confirm the rangle of the gauge.There have not been any similar occurences since the design was revised in 2014, and therefore it is an isolated incident.Please note: this report is filed with the fda due to an event experienced with a device that is similar to those placed on the market in the usa.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to the event.

• Brand Name: TRINITY
• Type of Device: FLEXIBLE DEPTH GAUGE
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: dardan uka ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 12164899
• MDR Text Key: 263503304
• Report Number: 9614209-2021-00086
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093472
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 07/29/2022

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: 921.109
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 058204-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 07/02/2021
• Initial Date FDA Received: 07/14/2021
• Supplement Dates Manufacturer Received: 07/02/2022
• Supplement Dates FDA Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1