MAUDE Adverse Event Report: GEOMED MEDIZIN-TECHNIK GMBH & CO. KG CARB-EDGE IRIS SCISSORS 4-1/2 STR.

Model Number 101300

Device Problem Material Fragmentation (1261)

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

Event Type  malfunction  

Manufacturer Narrative

Several attempts were made to obtain the device for inspection and investigation, but it was not returned to the manufacturer.The manufacturing lot number is unknown and it is impossible to review device manufacturing history.The complaint is considered closed.Should additional information become available, it will be reopened.

Event Description

A facility reported that the device was broken during use by the action of a small force.The fracture occurred during clamping in surgery.The broken piece of the instrument was found in the surgical site.It took time to prepare a replacement instrument.An unspecified delay in surgery occurred and the surgeon had to repeat the surgical procedure.

• Brand Name: CARB-EDGE IRIS SCISSORS 4-1/2 STR.
• Type of Device: SCISSORS
• 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: 16465730
• MDR Text Key: 310498193
• Report Number: 8010168-2023-00003
• Device Sequence Number: 1
• Product Code: HNF
• UDI-Device Identifier: 10381780375029
• UDI-Public: 10381780375029
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: EXEMPT
• 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: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101300
• Device Catalogue Number: 101300 / AD 784-11-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2023
• 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