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

Catalog Number AD 785-11-01 / 101301

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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 function testing and found to conform to specifications.The device was subject to microscopic inspection and no fracture of the tip was observed.No failure detected, device intact.

Event Description

According to the dealer, the instrument tip was broken during pediatric surgery.X-ray was taken to confirm no broken parts inside the patient.No harm done.

• Brand Name: GOLD-CUT IRIS SCISSORS SP/SP GEB 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: 6197786
• MDR Text Key: 63063222
• Report Number: 8010168-2016-00005
• Device Sequence Number: 1
• Product Code: HNF
• 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 785-11-01 / 101301
• Device Lot Number: 297
• 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: 10/29/2013
• 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