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

Catalog Number 530.710

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Event Description

It was reported from (b)(6) that during service and repair/pre-testing, it was observed that the battery oscillator device had mode switch stuck, sticky trigger, component damage, contact damage, high output/power and fluid ingress.It was further reported that the device¿s mode switch resistance was too high.The device also failed pretests for mode switch-test, oscillation frequency with frequency meter, sticky trigger and general condition.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The date of event was unknown but was known to have occurred in 2021.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional narrative: this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.An evaluation was performed and it was determined that the reported condition of sticky trigger identified during service and evaluation was confirmed.The assignable root cause was traced to component failure from wear.Udi: (b)(4).

• 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 Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6107428552
• MDR Report Key: 13112632
• MDR Text Key: 287555576
• Report Number: 8030965-2021-10526
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 07611819491847
• UDI-Public: 07611819491847
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• 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: 12/19/2021
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2017
• 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