MAUDE Adverse Event Report: COVIDIEN SILS CLINCH; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number SILSCLINCH36

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Burn(s) (1757)

Event Date 07/20/2016

Event Type  malfunction  

Event Description

During a sils appendectomy the surgeon was using cautery while using the clinch in the surgical field.The clinch grasper grounded on the periumbilical skin, causing a superficial burn.The sils (single insertion laparoscopic surgery) device insulation was not durable enough to support other instruments rubbing against it at the single insertion access point.

Event Description

During a sils appendectomy, the surgeon was using cautery while using the clinch in the surgical field.The clinch grasper grounded on the periumbilical skin, causing a superficial burn.The sils (single insertion laparoscopic surgery) device insulation was not durable enough to support other instruments rubbing against it at the single insertion access point.

• Brand Name: SILS CLINCH
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven, CT 06473
• MDR Report Key: 5895908
• MDR Text Key: 52766154
• Report Number: 5895908
• Device Sequence Number: 1
• Product Code: GCJ
• 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,Followup
• Report Date: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: SILSCLINCH36
• Device Lot Number: N6A0333X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14 YR
• Patient Weight: 72