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

Model Number	101300
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.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 or Problem 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.
• Common Device Name: 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
• Report Number: 8010168-2023-00003
• Device Sequence Number: 7774806
• Product Code: HNF
• UDI-Device Identifier: 10381780375029
• UDI-Public: 10381780375029
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Type of Report: Initial
• Report Date (Section B): 03/02/2023

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
• Operator of Device: Health Professional
• Device Model Number: 101300
• Device Catalogue Number: 101300 / AD 784-11-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown