MAUDE Adverse Event Report: AESCULAP AG ACCULAN 3TI RECIPROCATING SAW; SAW, POWERED, AND ACCESSORIES

Model Number GA674

Device Problem Power Problem (3010)

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

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with ga674 - acculan 3ti reciprocating saw.According to the complaint description, the medical staff found that after the acculan 3ti battery power system was installed in place, the switch was turned on, and the acculan 3ti battery power system had no output.Replaced other acculan 3ti battery power system and used normally.Contacted the medical engineering department for maintenance.The engineer found that the motor was faulty.No adverse effects on patient.There was no described patient harm.Additional information was not provided nor available / was not available.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Corrected data - g4 (510k exempt), h4.Additional information - a2, a3, d4 (serial #, lot #, udi).Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: there are no similar complaints against the same lot number with this error pattern.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: ACCULAN 3TI RECIPROCATING SAW
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11174250
• MDR Text Key: 227800141
• Report Number: 9610612-2020-00984
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GA674
• Device Catalogue Number: GA674
• Device Lot Number: 52220034
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 02/02/2021
• Supplement Dates FDA Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 YR