MAUDE Adverse Event Report: UMKIRCH DOUBLEAIRHOSE L5M F/SYST SYNTHES; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 519.530

Device Problem Air Leak (1008)

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

Event Date 10/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was determined to be due to improper handling, which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

This is report 4 of 4 for the same event.It was reported from (b)(6) that during an unspecified surgical procedure,it was observed that four air hose devices were leaking.It was not reported if there was a delay in the procedure due to the event.It was not reported if there was a spare device available to complete the procedure.There was patient involvement reported.There were no patient or user injuries reported.It was reported there was no medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: DOUBLEAIRHOSE L5M F/SYST SYNTHES
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): UMKIRCH; im kirchenhurstle 4; umkirch b. freiburg D-792 24; GM D-79224
• Manufacturer (Section G): UMKIRCH; im kirchenhurstle 4; umkirch b. freiburg D-792 24; GM D-79224
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6368080
• MDR Text Key: 68971147
• Report Number: 3003862213-2017-10009
• Device Sequence Number: 1
• Product Code: HSZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 519.530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: DOUBLE AIR-HOSE DEVICES