MAUDE Adverse Event Report: DRYSDALE NUCLEUS MANIPULATOR; HOOK, OPHTHALMIC

Model Number 86-1752

Device Problem Break (1069)

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

Event Date 08/20/2020

Event Type  Injury  

Event Description

Tip of instrument broke off in patient's operative eye.(b)(6).Fda safety report id# (b)(4).

• Brand Name: DRYSDALE NUCLEUS MANIPULATOR
• Type of Device: HOOK, OPHTHALMIC
• MDR Report Key: 10494288
• MDR Text Key: 205946358
• Report Number: MW5096445
• Device Sequence Number: 1
• Product Code: HNQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 86-1752
• Device Catalogue Number: 86-1752
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 64