MAUDE Adverse Event Report: ARTHROCARE CORP. AMBIENT HIPVAC 50 IFS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number ASHA4730-01

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during an unknown procedure, while the wand was being used the end of the wand cracked.The procedure was completed with a backup device with no delay or patient injury reported.

Event Description

It was reported that during a hip arthroscopy, while the wand was being used the end of the wand cracked.The procedure was completed with a backup device with no delay or patient injury reported.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined since the product was not returned for evaluation.Visual inspection and functional testing could not be performed because the device in question was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.Factors not associated with the manufacture or design of the device which could result in damage to the tip could be the device coming into abrupt contact with a hard (metallic) object, improper insertion or removal from an apparatus, use at a higher than recommended set point or excessive force applied to the tip can also lead to unintended detachment and are outlined in the precautionary statements in the instruction for use.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: AMBIENT HIPVAC 50 IFS
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8755849
• MDR Text Key: 150278710
• Report Number: 3006524618-2019-00315
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470000436
• UDI-Public: 00817470000436
• Combination Product (y/n): N
• PMA/PMN Number: K083306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2021
• Device Catalogue Number: ASHA4730-01
• Device Lot Number: 2020967
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 07/02/2019
• Supplement Dates Manufacturer Received: 07/03/2019; 07/29/2019
• Supplement Dates FDA Received: 07/03/2019; 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1