MAUDE Adverse Event Report: SYNTHES GMBH BATTERY OSCILLATOR II FOR BPL II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 530.710

Device Problem Unintended System Motion (1430)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device had unintended motion, a worn motor, the speed could not be controlled or changed, and insufficient/low power.Therefore, the reported condition that the oscillator head did not work was confirmed.The assignable root cause of this condition was determined to be traced to component failure due to normal wear.Udi ¿ (b)(4).

Event Description

It was reported from (b)(6) that during service and evaluation, it was determined that the battery oscillator device motor was worn and defective, the speed of the device could not be controlled/changed, insufficient/low power, and unintended activation/motion.It was further determined that the device failed pretest for mode-switch test, check oscillation frequency, and check for unintended motion.It was noted in the service order that during an unspecified surgical procedure it was observed that the oscillator head did not work.It was reported that there were no delays to the surgical procedure.There were no reports of injuries, medical intervention, or prolonged hospitalization.The exact date of the event was not reported, however, it was reported that the event occurred in 2020.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: BATTERY OSCILLATOR II FOR BPL II
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 10854395
• MDR Text Key: 243069441
• Report Number: 8030965-2020-08797
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 07611819491847
• UDI-Public: 7611819491847
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Date Manufacturer Received: 11/04/2020
• Date Device Manufactured: 06/26/2018
• 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