MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CLIP GUN; CLIP, SCALP

Model Number CG8900

Device Problems Component Falling (1105); Device Operates Differently Than Expected (2913)

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

Event Date 02/09/2016

Event Type  malfunction  

Event Description

Unable to count raney clips because applicator is pre-loaded by the manufacturer with an inconsistent number of clips.Unable to check for retained item with imaging because clips are not radiopaque.Applicator will also drop clips in the surgical site if it is accidentally tapped, making it impossible to know how many clips have been used.The poor quality of this product and concern for patient safety is an issue for every cranioplasty case because there are no alternative products on the market.We would like to suggest that the applicator be manually loaded so that a pre-count could be performed and raney clips be included in our counting protocol.We also suggest that the clips be available in a radiopaque material so that we could capture clips on imaging in the event of an incorrect count.

Event Description

While investigating ways to prevent retained raney clips, surgeons reported challenges related to counting this item: the clip applicator is pre-loaded by the manufacturer with an inconsistent number of clips (usually +/- 1 or 2) and cannot be counted in the pre-count.The gun sometimes releases more than one clip (this may be that the user was holding down the trigger or the trigger was overly sensitive).Because of these challenges with counting the clips, the surgical team would like a radiopaque option for raney clips so that x-ray may be used to check for retained clips.

• Brand Name: CLIP GUN
• Type of Device: CLIP, SCALP
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6367797
• MDR Text Key: 68613034
• Report Number: 6367797
• Device Sequence Number: 1
• Product Code: HBO
• 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: 01/24/2017,01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CG8900
• Device Catalogue Number: CG8900
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/24/2017
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/17/2017
• 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
• Treatment: NO; NO