MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY MNS UNKNOWN CLIPGUN; CLIP, SCALP

Catalog Number UNKNOWN-G

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

It is unknown whether the reported device was a medtronic product.The product was unavailable for return.Therefore, an evaluation of device performance was not possible.A review of the manufacturing records was not possible as no lot number was provided.The instructions for use that accompany the medtronic clip gun kit specify that the clip gun kit containing a clip gun, pre-loaded magazines with scalp clips, and removal forceps is a single-use disposable kit.(b)(4).

Event Description

It was reported to medtronic neurosurgery that the disposable surgical scalp clip used to prevent bleeding was left in during a cranial surgery that resulted in a second surgical procedure to remove the surgical scalp clip.According to the report, immediately upon learning of the retained foreign body, the patient was taken to the operating room for removal of the raney clip on (b)(6) 2013.The report stated that there were no apparent sequelae as a result of the retained raney clip or the surgical removal.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: MNS UNKNOWN CLIPGUN
• Type of Device: CLIP, SCALP
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: jeffrey henderson ; 125 cremona drive; goleta, CA 93117 ; 8055718445
• MDR Report Key: 5368871
• MDR Text Key: 36027855
• Report Number: 2021898-2016-00022
• 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: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN-G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2015
• Initial Date FDA Received: 01/14/2016
• Supplement Dates Manufacturer Received: 12/15/2015
• Supplement Dates FDA Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1