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

Device Problems Loose or Intermittent Connection (1371); Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 05/17/2023

Event Type  malfunction  

Event Description

Two bipolar cords were defective.Bipolar cords would not stay plugged in to esu(electrosurgical unit).The right side connector was loose and would fall out.Two bipolar cords not used on patient were wasted.Third bipolar cord was obtained and used.Pt undergoing septoplasty bilateral maxillary antrostomy with tissue removal, bilateral total ethmoidectomy, bilateral endoscopic sphenoidotomy, bilateral endoscopic frontal sinusotomy.No injury to the patient.Reference report: mw5117816.

• Brand Name: DISPOSABLE BIPOLAR CORD
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): KIRWAN SURGICAL PRODUCTS, LLC.; marshield MA 02051
• MDR Report Key: 17001956
• MDR Text Key: 316008968
• Report Number: MW5117817
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White