MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN CLIPGUN; HEMOSTAT, SURGICAL

Catalog Number UNKNOWN-G

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2014

Event Type  Injury  

Event Description

It was reported to medtronic neurosurgery that a clip was inadvertently left in a patient.The patient was initially operated on (b)(6) 2014.For unrelated reasons to the clip, she was reoperated on (b)(6) 2014.The clip was discovered to be left in the patient during the second operation.It was also reported that there was no harm to the patient.

Manufacturer Narrative

The product was not returned.Therefore an evaluation of the device performance was not possible.A review of the manufacturing records was not possible as a lot number was not provided.(b)(4).

Manufacturer Narrative

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

• Brand Name: UNKNOWN CLIPGUN
• Type of Device: HEMOSTAT, SURGICAL
• 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: 4233592
• MDR Text Key: 5066978
• Report Number: 2021898-2014-00440
• Device Sequence Number: 1
• Product Code: EMD
• 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,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/08/2014

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2014
• Initial Date FDA Received: 11/06/2014
• Supplement Dates Manufacturer Received: 10/08/2014
• Supplement Dates FDA Received: 09/15/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other