MAUDE Adverse Event Report: SYNTHES OBERDORF LI-ION BATTERY, NON-STERILE; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 530.630_DL

Device Problem Loss of Power (1475)

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

Event Date 05/14/2014

Event Type  malfunction  

Event Description

It was reported that the battery device lost power in the operating room right before use.There were no delays to the planned surgical procedure, as a spare device was available for use.There were no reports of injuries, 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.

Manufacturer Narrative

The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was not duplicated or confirmed.An assessment was performed on the device which determined the device passed all operational specifications.Therefore, an assignable root cause was not determined.If additional information should become available, a supplemental medwatch report will be sent accordingly.

• Brand Name: LI-ION BATTERY, NON-STERILE
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer (Section G): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4793682
• MDR Text Key: 5881479
• Report Number: 8030965-2015-10741
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.630_DL
• Device Lot Number: 121015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1