MAUDE Adverse Event Report: INSTRUMED INTERNATIONAL, INC. BOSS; OVAL WINDOW PICK, .33MM PT ANG 90DEG

Catalog Number 90-3325

Device Problem Break (1069)

Patient Problem Hearing Impairment (1881)

Event Type  Injury  

Event Description

Tip broke during surgery on pediatric patient.Surgeon could not retrieve tip.

Manufacturer Narrative

Actual date of event unknown.This is not a single use device.Class 1 exempt.The actual device was reviewed.A dhr review was also conducted and there were no deviations noted.Mfr date: 11/2013.

• Brand Name: BOSS
• Type of Device: OVAL WINDOW PICK, .33MM PT ANG 90DEG
• Manufacturer (Section D): INSTRUMED INTERNATIONAL, INC.; schaumburg IL
• Manufacturer (Section G): INSTRUMED GMBH; unter buchsteig 3; tuttlingen 7853 2; GM 78532
• Manufacturer Contact: jennifer staunton ; 626 cooper court; schaumburg, IL 60173 ; 8479086619
• MDR Report Key: 4244863
• MDR Text Key: 21879603
• Report Number: 1421101-2014-00001
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 90-3325
• Device Lot Number: 020213 / 110213
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/08/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1