MAUDE Adverse Event Report: GEOMED MEDIZIN-TECHNIK GMBH & CO. KG GOLD-CUT IRIS SCISSOR SH/SH CVD 11.5CM; OPHTHALMIC SCISSORS

Model Number	5-306TC
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
Despite several attempts to obtain the device or photographs of the device, the scissors were not returned.Therefore, it was impossible to perform an evaluation of the device.It was also impossible to determine the batch code of the device in order to review the dhr.Review of complaint history did not reveal any similar nonconformances.
Event or Problem Description
Per the healthcare facility, the device snapped during surgical excision.A metallic piece was found within the deficit.A two-hour surgical delay in the procedure was reported.No patient injury or death occurred.

• Brand Name: GOLD-CUT IRIS SCISSOR SH/SH CVD 11.5CM
• Common Device Name: OPHTHALMIC 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: 14217632
• Report Number: 8010168-2022-00002
• Device Sequence Number: 20224465
• Product Code: HNF
• UDI-Device Identifier: 10381780437277
• UDI-Public: 10381780437277
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Type of Report: Initial
• Report Date (Section B): 04/27/2022

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: 5-306TC
• Device Catalogue Number: 5-306TC / AD 785-11-01
• Device Lot Number: AA2004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• 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