MAUDE Adverse Event Report: SMITH NEPHEW, INC. COBLATION; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number AC4330-01

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/02/2021

Event Type  malfunction  

Event Description

Tip of saber 30 degrees broke off in pt.Left shoulder.Per surgeon operative note for surgical procedure of arthroscopic rotator interval release: a 7 mm cannula was inserted through the anterior superior portal as the 5 mm cannula would not fit the hook tip radiofrequency device.Apparently, smith and nephew, the manufacturer of these instruments had changed the hook tip radiofrequency device to a curved instrument with about a 10-degree curve or so and this required a 7 mm cannula for its insertion.The surgeon inserted the cannula and then using the radiofrequency tip opened the dense scarred rotator interval down to the level of the subscapularis.This notably improved external rotation to at least 30 degrees.The surgeon then continued releasing with a radiofrequency device through the middle glenohumeral ligament and the inferior glenohumeral ligament.The surgeon then removed the cannula and inserted the radiofrequency device in order to have an unimpeded approach to the anterior and inferior capsule and released this as well down to about the 5 o'clock position.Upon removing the hook tip radiofrequency device, it was evident that the tip had broken.There was no evidence of it within the joint.The surgeon visualized through not only the posterior portal, but the anterior portal.Radiology called and took shoulder x-ray upon which item was seen by the surgeon.The surgeon stated the size of the tip is 2mm and unable to retrieve for safety of patient and shoulder.Manufacturer response for electrosurgical, cutting coagulation accessories, coblation (per site reporter): unknown.

• Brand Name: COBLATION
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): SMITH NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 13235683
• MDR Text Key: 283669313
• Report Number: 13235683
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AC4330-01
• Device Catalogue Number: AC4330-01
• Device Lot Number: 2039774
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22630 DA
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Race: White