MAUDE Adverse Event Report: GEOMED MEDIZIN-TECHNIK GMBH & CO. KG GOLD-CUT IRIS SCISSORS SP/SP GER 11.5CM; SURGICAL SCISSORS

Catalog Number AD 784-11-01 / 101300

Device Problems Fracture (1260); Off-Label Use (1494)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device history record, including acceptance testing results, was reviewed and found to conform to specifications.The device was subject to microscopic inspection and showed no signs of pre-existing material damage due to stress corrosion cracking, which indicates that the device may have been subject to inappropriate use.It must also be considered that the scissors involved in the event are delicate scissors intended for ophthalmic use, not for ent surgery.However, due to the fact that the device was returned incomplete, i.E., the broken-off tip is not available for inspection, it has not been possible to conclusively establish the cause of failure.

Event Description

According to the dealer, the instrument tip was broken during ent surgery.No broken parts inside the patient.No harm done.

• Brand Name: GOLD-CUT IRIS SCISSORS SP/SP GER 11.5CM
• Type of Device: SURGICAL SCISSORS
• Manufacturer (Section D): GEOMED MEDIZIN-TECHNIK GMBH & CO. KG; ludwigstaler strasse 27; tuttlingen, baden-wuerttemberg 78532 ; GM 78532
• Manufacturer (Section G): GEOMED MEDIZIN-TECHNIK GMBH & CO. KG; ludwigstaler strasse 27; tuttlingen, baden-wuerttemberg 78532 ; GM 78532
• Manufacturer Contact: hanno haug ; ludwigstaler strasse 27; tuttlingen, baden wuerttemberg 78532 ; GM 78532 ; 746193550
• MDR Report Key: 6197783
• MDR Text Key: 63489691
• Report Number: 8010168-2016-00004
• Device Sequence Number: 1
• Product Code: HRR
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: N/A
• 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: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AD 784-11-01 / 101300
• Device Lot Number: 248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2016
• Date Manufacturer Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2013
• 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