MAUDE Adverse Event Report: KEELER INSTRUMENTS, INC. CRYOMATIC; UNIT, CRYOPHTHALMIC, AC-POWERED

Device Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

Patient Problem Laceration(s) (1946)

Event Date 09/15/2015

Event Type  Injury  

Event Description

Patient was undergoing right eye pneumatic retinopexy to repair right retinal detachment.Reportedly, the cryoprobe had been checked by staff prior to procedure and found to frost/defrost appropriately.Per medical record, approximately three to four cryotherapy spots were placed around the retinal tear without incident.However, on the fourth activation the probe would not defrost following deactivation of the foot pedal and could not be removed.Reportedly, this resulted in a prolonged freeze.Surgeon then placed countertraction on the globe in order to remove the probe.Patient sustained a conjunctival laceration which was repaired with two sutures.The cryomachine was taken out of service and replaced with a second machine.Procedure completed without further incident.

• Brand Name: CRYOMATIC
• Type of Device: UNIT, CRYOPHTHALMIC, AC-POWERED
• Manufacturer (Section D): KEELER INSTRUMENTS, INC.; 456 pkwy.; broomall PA 19008
• MDR Report Key: 5123513
• MDR Text Key: 27378964
• Report Number: 5123513
• Device Sequence Number: 1
• Product Code: HRN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Other Device ID Number: 4206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/01/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2015
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2015
• 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: 67 YR
• Patient Weight: 62