MAUDE Adverse Event Report: HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS DOPPLEX; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	DIOP8
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure the single use probe faceplate became detached from the probe body.However it stayed connected via the wire assembly being attached.
Additional Manufacturer Narrative
Investigation is in progress.The follow-up report will be sent when investigation conclusion is available.
Additional Manufacturer Narrative
Res# (b)(4).One diop8 probe from batch (10) 7842006001 failed during use.Faceplate come away from probe body but still attached via wire.This was reported to us via e medical (bas) after normal working hours on thursday evening (b)(6) 2022.User is st jansdal in netherlands actual name of surgeon is unknown.There was no injury to the patient.(b)(4) inspected.Review of inspection results confirmed problem batch to be (10) 7842006001.No other failures found in any other batches.Tolerance analysis confirmed probe parts were correct to specification but highlighted the glue bond is not in the optimal position for best bonding results.2 root cause have been established.1.A check of faceplate bond was not in place for the 1st initial manufacturing batch as the pfmea was initiated too late in the design transfer process.2.The position of bond of the faceplate to the probe tube is not in the optimal position.All problem devices (unused removed from use).Field action complete, problem batch of (b)(4) located and disposed of where required.Root cause has been established.100% verification pass rate of revised faceplate bond method.Qualifying the manual process (doc 7841054_29-03-2022) had 100% pass rate for revised faceplate bond method.The process was repeatable with no bond failures found during rotational testing.Capa01-22 is now in it's effectiveness stage.

• Brand Name: DOPPLEX
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS; 35 portmanmoor road; splott; cardiff, CF24 5HN; UK CF24 5HN
• Manufacturer (Section G): HUNTLEIGH HEALTHCARE LTD; 35 portmanmoor road; splott; cardiff, CF24 5HN; UK CF24 5HN
• Manufacturer Contact: steve monks ; 35 portmanmoor road; splott; cardiff, CF24 -5HN ; UK CF24 5HN
• MDR Report Key: 13418038
• Report Number: 1000589001-2022-00001
• Device Sequence Number: 14642986
• Product Code: ITX
• UDI-Device Identifier: 05051968036544
• UDI-Public: (01)05051968036544
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: 505
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2022

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
• Operator of Device: Health Professional
• Device Model Number: DIOP8
• Device Catalogue Number: DIPP10
• Device Lot Number: 107842006001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Supplement Date Received by Manufacturer: 05/03/2022; 01/20/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 06/02/2022; 09/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0960-2022
• Patient Sequence Number: 1
• Patient Sex: Unknown