MAUDE Adverse Event Report: KIRWAN SURGICAL PRODUCTS LLC. BIPOLAR PENCIL; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 14-5011

Device Problems Component Falling (1105); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/17/2016

Event Type  malfunction  

Event Description

During a vitrectomy procedure of the left eye, a bipolar cautery was being used by the surgeon and after removing the device from the eye he noticed a piece had remained.A metal sleeve covering the bipolar tip had dislodged from the pencil and came off and remained in the eye.The surgeon immediately removed the metal piece from the eye and asked to replace the pencil with a new one.

• Brand Name: BIPOLAR PENCIL
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): KIRWAN SURGICAL PRODUCTS LLC.; 180 enterprise dr.; marshfield MA 02050
• MDR Report Key: 6188723
• MDR Text Key: 62823964
• Report Number: 6188723
• Device Sequence Number: 1
• Product Code: GEI
• 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
• Type of Report: Initial
• Report Date: 11/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 14-5011
• Device Lot Number: 012216
• Other Device ID Number: 25 GUAGE
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/25/2016
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/25/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: 25-GAGE TROCARS, RETROBULBAR BLOCK 50,50 MARVAINE,
• Patient Age: 77 YR