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

Device Problem Material Fragmentation (1261)

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

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 299292661
• Report Number: 8010168-2022-00002
• Device Sequence Number: 1
• Product Code: HNF
• UDI-Device Identifier: 10381780437277
• UDI-Public: 10381780437277
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• 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