MAUDE Adverse Event Report: GEOMED MEDIZIN-TECHNIK GMBH & CO. KG CARB-BITE MAYO-HEGAR NEEDLE HOLDER 6

Catalog Number 121-135 / AR 200-16-61

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

The needle holders mentioned in the facility narrative have not been returned for inspection.It has therefore not been possible to confirm the alleged failures (broken tip, suture not held) nor the identity of the foreign body detected on the x-ray.The lot number is not available and manufacturing history cannot be reviewed.Repeated attempts have been made to obtain additional information from the healthcare facility.If additional information is obtained, a supplemental report will be submitted.

Event Description

While using the 121135 carb-bite mayo-hegar needle holder 6 on a patient during an unspecified procedure, the device failed to hold suture.The surgeon tried using a second 121135 carb-bite mayo-hegar needle holder 6, but it also failed to hold suture.Postoperatively, after the closure of the patient, an x-ray was taken.A foreign body was seen on the film.The scrub technician went back to the tray and noticed that the device had a broken tip.The patient was later brought back into surgery and had the needle holder tip removed.There was an unspecified injury and delay in surgery reported.(event report for device #1 of 2).

• Brand Name: CARB-BITE MAYO-HEGAR NEEDLE HOLDER 6
• 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, baden wuerttemberg 78532 ; GM 78532
• MDR Report Key: 9098906
• MDR Text Key: 164167978
• Report Number: 8010168-2019-00001
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 10381780377160
• UDI-Public: 10381780377160
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2019

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 Catalogue Number: 121-135 / AR 200-16-61
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2019
• Initial Date FDA Received: 09/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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