MAUDE Adverse Event Report: GEOMED MEDIZIN-TECHNIK GMBH & CO. KG CARB-BITE MAYO-HEGAR NEEDLEHOLDER 7; CARDIOVASCULAR NEEDLEHOLDER

Model Number AR 200-18-61

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

Inspection of photos of the affected device showed that the device had been inadequately "repaired" by unauthorized third parties who did not adhere to the original manufacturing specifications.The etched label was covered with tape and the originally matte-finished instrument was sandblasted.Silver solder was used on the jaw of the instrument, as indicated by the yellowish color of the tip.This material is not used during the manufacturing process and is not adequate for this device.To complete the investigation, the device itself and the broken-off insert will need to be inspected.Return of the device has been requested.

Event Description

While using the 121140 carb-bite mayo-hegar nh 7, the tungsten carbide insert came off the needle holder.Piece was retrieved and sent with needle holder to clinical engineering.There was patient contact, however, there was no patient injury or harm.There was no surgical delay.Both the device and the broken piece were saved.

• Brand Name: CARB-BITE MAYO-HEGAR NEEDLEHOLDER 7
• Type of Device: CARDIOVASCULAR 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: 9600196
• MDR Text Key: 207517406
• Report Number: 8010168-2020-00001
• Device Sequence Number: 1
• Product Code: DWS
• 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: 01/17/2020

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: No Information
• Device Model Number: AR 200-18-61
• Device Catalogue Number: 121-140
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/17/2020
• 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: Reuse
• Patient Sequence Number: 1