MAUDE Adverse Event Report: GEOMED MEDIZIN-TECHNIK GMBH & CO. KG GOLD-GRIP HEANEY NEEDLE HOLDER CVD 21CM; NEEDLEHOLDER

Catalog Number	121-210 / AR 411-21-61
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Several attempts were made to obtain the device for inspection and investigation, but it was not returned to the manufacturer.Manufacturing history was reviewed and no issues were found.Since the device was manufactured in 2018, it is possible that the problem occurred due to normal wear over time.The complaint is considered closed.Should additional information become available, it will be reopened.
Event or Problem Description
During a total laparoscopic hysterectomy, bilateral salpingectomy and cystoscopy the surgeon noticed that a piece of the needleholder had broken off in the patient's vagina while suturing the vaginal cuff.The piece was retrieved and the instrument and broken piece were immediately removed from the field.An x-ray was not necessary.The procedure was completed as planned.No patient harm or surgical delay occurred as a result.

• Brand Name: GOLD-GRIP HEANEY NEEDLE HOLDER CVD 21CM
• Common Device Name: NEEDLEHOLDER
• 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: 17399155
• Report Number: 8010168-2023-00006
• Device Sequence Number: 12677027
• Product Code: FHQ
• UDI-Device Identifier: 10381780377474
• UDI-Public: 10381780377474
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 121-210 / AR 411-21-61
• Device Lot Number: AA1803 / 135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 106 KG