MAUDE Adverse Event Report: GEOMED MEDIZIN-TECHNIK GMBH & CO. KG CARB-BITE DEBAKEY NEEDLEHOLDER; NEEDLE HOLDER

Model Number 121186

Device Problem Material Fragmentation (1261)

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

Event Date 08/30/2022

Event Type  malfunction  

Event Description

It was reported that during a heart operation, the surgeon noticed that a piece of the needle holder was missing.Before the end of the operation, an x-ray was taken.The missing piece was not found in the patient's body.Medical staff did not know at which stage the device broke, but suspected it was at the beginning of the operation.The event did not lead to patient injury, but a two-hour increase in surgery time was reported.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

The following form fields have been updated: d4, d9, h2, h3, h6, h10.The device was returned to the manufacturer.Inspection of the returned device revealed that it was manufactured by another company.The manufacturer of the device is unknown.The relabeler has been informed accordingly.The investigation has been closed.

• Brand Name: CARB-BITE DEBAKEY NEEDLEHOLDER
• Type of Device: NEEDLE HOLDER
• Manufacturer (Section D): GEOMED MEDIZIN-TECHNIK GMBH & CO. KG; ludwigstaler strasse 27; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): GEOMED MEDIZIN-TECHNIK GMBH & CO. KG; ludwigstaler strasse 27; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: hanno haug ; ludwigstaler strasse 27; tuttlingen, bw 78532 ; GM 78532
• MDR Report Key: 16110119
• MDR Text Key: 307814491
• Report Number: 8010168-2023-00001
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 10381780165071
• UDI-Public: 10381780165071
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 121186
• Device Catalogue Number: 121186 / AR 278-20-61
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 01/05/2023
• Supplement Dates Manufacturer Received: 01/10/2023
• Supplement Dates FDA Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male