MAUDE Adverse Event Report: S.U.A. MARTIN GMBH &CO.KG YARARGIL MICRO DISSECTOR BAYO 7-1/4 ARACHNOID; MICRO DISSECTORS

Catalog Number RB9344 / 10138

Device Problems Bent (1059); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

The photographs supplied by the user show considerable device damage: the tip was bent and the blade had broken off.When used in accordance with its intended use, the device cannot break.The device was apparently damaged due to misuse or rough handling, such as falling to the ground.Manufacturing records, including acceptance testing records, were checked for the lot in question and found to be conforming.No similar complaints have been received for this device.The root cause of the damage cannot be established since the device is not available for inspection and testing.

Event Description

During use, the tip of the device is reported to have broken and fallen into the patient's brain cavity.The surgeon retrieved the broken tip from the patient.A 15-minute delay of the surgery occurred.Surgery was completed with other instruments and the patient was fine.

• Brand Name: YARARGIL MICRO DISSECTOR BAYO 7-1/4 ARACHNOID
• Type of Device: MICRO DISSECTORS
• Manufacturer (Section D): S.U.A. MARTIN GMBH &CO.KG; uhlandstrasse 17; rietheim-weilheim, 78604 ; GM 78604
• Manufacturer (Section G): S.U.A. MARTIN GMBH &CO.KG; uhlandstrasse 17; rietheim-weilheim, 78604 ; GM 78604
• Manufacturer Contact: markus pauli ; uhlandstrasse 17; rietheim-weilheim, 78604 ; GM 78604
• MDR Report Key: 7477385
• MDR Text Key: 107705016
• Report Number: 8010386-2018-00004
• Device Sequence Number: 1
• Product Code: GZX
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RB9344 / 10138
• Device Lot Number: 100180-1608
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2016
• 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
• Patient Age: 45 YR